Apparatus for controlling flow in a bodily organ

ABSTRACT

An apparatus for controlling the flow of urine in a urethra of a patient, comprising an implantable adjustable constriction device for constricting the urethra, a control device for controlling the constriction device, an operation device for operating the constriction device to change the constriction of the urethra, and an energy source for supplying energy for the operation device. The control device comprises a temperature sensor configured to sense a temperature of the apparatus or a temperature of the patient.

FIELD OF THE INVENTION

The present invention relates to controlling the flow of fluids and/orother bodily matter in bodily organs, and in particular, to an apparatusfor controlling the flow of fluids and/or other bodily matter in lumensformed by tissue walls of bodily organs, such as (but not limited to)the esophagus, stomach, intestines, urine bladder, urethra, and bloodvessels.

BACKGROUND OF THE INVENTION

There are diseases that prevent a patient from maintaining normalcontrol of the flow of fluids and/or other bodily matter in a lumen of abodily organ. (The term “patient” generally includes human beings, butmay also include animals.) For example, a patient suffering from urinaryincontinence, which is a common disease that is very embarrassing to apatient, typically occurs where the patient has lost full control ofurine flow in the urethra because of a malfunctioning of the urethralsphincter. Anal incontinence often occurs because of a malfunctioning ofthe anal sphincter, which causes an uncontrolled drainage of fecalmatter through the anus. Impotence is typically due to an inability tosufficiently reduce blood flow from the penis so that an refection canbe achieved. Reflux disease is typically due to a malfunctioning of thecardia, which causes stomach acids to be regurgitated into the esophaguswhen the stomach wall moves during digestion.

One prior solution to the problem of malfunctioning sphincters has beento implant an artificial sphincter that replaces a malfunctioningsphincter. A variety of artificial sphincters have been used in thepast. These artificial sphincters have included cuffs, clamping elementsor inflatable bands that are applied externally around the bodily organthat is connected to the malfunctioning sphincter.

For example, U.S. Pat. No. 3,750,194 discloses a hydraulic cuff appliedaround the urethra of a patient suffering from urinary incontinenceHydraulic fluid flowing to the hydraulic cuff causes the cuff to squeezethe urethra and restrict fluid flow through it.

U.S. Pat. No. 6,074,341 discloses a mechanical device in the form of aloop member that is applied around a bodily organ to replace the organ'smissing or damaged sphincter. The loop member includes a wire which isused to constrict the organ in question to close the lumen therein.

A disadvantage common to all prior artificial sphinters is that hardfibrosis may form around the artificial sphincter over time and maycause malfunction of the artificial sphincter. Thus, the formed fibrosismay sooner or later become a hard fibrotic layer which may make itdifficult for the artificial sphincter to work.

Another more serious disadvantage is that the element that constricts,clamps or restricts a bodily organ may injure the tissue wall of theorgan. Thus, a consequence of the element's constricting action on theorgan is that the element might erode into the organ over time, and in aworst case, penetrate the constricted wall portion of the organ. Inaddition, blood circulation in the constricted tissue wall portion ofthe organ is eventually hampered by the pressure exerted by the element,so that poor blood circulation, or worse, no blood circulation resultsin deterioration of the constricted tissue.

One solution to prevent tissue deterioration due to poor bloodcirculation could be to apply two or more separately operatingconstricting elements along respective tissue wall portions of the organand operate the elements sequentially, whereby each tissue wall portionwould have time to recover, i.e., restore normal blood circulation whileone of the other tissue wall portions is constricted. However, anapparatus devised in accordance with this solution would have severaldisadvantages. First, the apparatus would require a large amount ofspace, making it impractical to implant. Second, the operation of theapparatus in moving the constricting elements between constricting andnon-constricting positions day and night would require a large powersupply. Such a large power supply would necessitate the implantation ofa very large, high capacity battery and/or a sophisticated system forcontinuous wireless transmission of energy from outside the patient'sbody for frequent charging of an implanted rechargeable battery. Thus,because of its large size and high power consumption, the apparatuswould be impractical or even unrealistic. Third, a sophisticated controlsystem would be necessary to control the moving elements. Finally, sucha complicated apparatus of the type described above would significantlyadd to the costs of treating a malfunctioning sphincter.

Another solution to the problem of malfunctioning sphincters that hasbeen previously used has been the electric stimulation of the sphincter,to restore its normal function, i.e., the contraction and closing of itsassociated lumen. This solution would work where the normal sphinctericfunction is somewhat reduced and has not completely ceased. Europeanpatent application 1004330 A1 discloses an example of such a solution,in which electric pulses are delivered to the lower esophageal sphincterof a patient suffering from reflux disease to minimize reflux. However,the esophageal sphincter has to be continuously stimulated with electricpulses to keep it closed, except when the patient eats, which may resultin a decreased stimulation effect over time. An even more seriousdrawback to this solution is that the continuous stimulation over timemight cause tissue deterioration due to poor blood circulation.

The use of electric stimula to restore the sphincteric function of amalfunctioning sphincter is only possible if the sphincter respondssufficiently to the stimula, i.e., closes the lumen in question. Incases where the sphincteric function of a sphincter has completelyceased, or the sphincter has been removed from the patient's body,electric stimulation cannot be employed.

Electric stimulation of bodily organs other than sphincters can onlyinsignificantly affect the flow in the organ in question. For example,where the organ is the small intestine of an anal incontinent patient,electric stimulation of the small intestine affects fecal flow, butcould not possibly fully close the fecal passageway, at least not byemploying the necessary low stimulation intensities that are harmless tothe human body.

BRIEF SUMMARY OF THE INVENTION

The object of the present invention is to provide an apparatus forcontrolling the flow of fluids and/or other bodily matter in lumensformed by tissue walls of bodily organs, so as to at least substantiallyor even completely eliminate the injured tissue wall problems that haveresulted from implanted prior art devices that constrict such bodilyorgans.

In accordance with this object of the present invention, there isprovided an apparatus for controlling the flow of fluids and/or otherbodily matter in a lumen that is formed by the tissue wall of a bodilyorgan, the apparatus comprising an implantable constriction device forgently constricting a portion of the tissue wall to influence the flowin the lumen, a stimulation device for stimulating the wall portion ofthe tissue wall, and a control device for controlling the stimulationdevice to stimulate the wall portion as the constriction deviceconstricts the wall portion to cause contraction of the wall portion tofurther influence the flow in the lumen.

The present invention provides an advantageous combination ofconstriction and stimulation devices, which results in a two-stageinfluence on the flow of fluids and/or other bodily matter in the lumenof a bodily organ. Thus, the constriction device may gently constrictthe tissue wall by applying a relatively weak force against the wallportion, and the stimulation device may stimulate the constricted wallportion to achieve the desired final influence on the flow in the lumen.The phrase “gently constricting a portion of the tissue wall” is to beunderstood as constricting the wall portion without substantiallyhampering the blood circulation in the tissue wall.

Preferably, the stimulation device is adapted to stimulate differentareas of the wall portion as the constriction device constricts the wallportion, and the control device controls the stimulation device tointermittently and individually stimulate the areas of the wall portion.This intermittent and individual stimulation of different areas of thewall portion of the organ allows tissue of the wall portion to maintainsubstantially normal blood circulation during the operation of theapparatus of the invention.

The combination of the constriction and stimulation devices enablesapplication of the apparatus of the invention at any place on any kindof bodily organs, in particular, but not limited to, tubular bodilyorgans, which is a significant advance in the art, as compared withprior stimulation devices that are confined to electric stimulation ofmalfunctioning sphincters.

In most applications using the present invention, there will be dailyadjustments of the implanted constriction device. Therefore, in apreferred embodiment of the invention, the constriction device isadjustable to enable adjustment of the constriction of the wall portionas desired, wherein the control device controls the constriction deviceto adjust the constriction of the wall portion. The control device maycontrol the constriction and stimulation devices independently of eachother, and simultaneously. Optionally, the control device may controlthe stimulation device to stimulate, or to not stimulate the wallportion while the control device controls the constriction device tochange the constriction of the wall portion.

Initially, the constriction device may be calibrated by using thecontrol device to control the stimulation device to stimulate the wallportion, while controlling the constriction device to adjust theconstriction of the wall portion until the desired restriction of theflow in the lumen is obtained.

Flow Restriction

The apparatus of the present invention is well suited for restrictingthe flow of fluids and/or other bodily matter in the lumen of a bodilyorgan. Thus, in a principal embodiment of the invention, theconstriction device is adapted to constrict the wall portion to at leastrestrict the flow in the lumen, and the control device controls thestimulation device to cause contraction of the constricted wall portion,so that the flow in the lumen is at least further restricted.Specifically, the constriction device is adapted to constrict the wallportion to a constricted state in which the blood circulation in theconstricted wall portion is substantially unrestricted and the flow inthe lumen is at least restricted, and the control device controls thestimulation device to cause contraction of the wall portion, so that theflow in the lumen is at least further restricted when the wall portionis kept by the constriction device in the constricted state.

The constriction and stimulation devices may be controlled to constrictand stimulate, respectively, to an extent that depends on the flowrestriction that is desired to be achieved in a specific application ofthe apparatus of the invention. Thus, in accordance with a first flowrestriction option, the control device controls the constriction deviceto constrict the wall portion, such that flow in the lumen is restrictedbut not stopped, and controls the stimulation device to stimulate theconstricted wall portion to cause contraction thereof, such that flow inthe lumen is further restricted but not stopped. More precisely, thecontrol device may control the stimulation device in a first mode tostimulate the constricted wall portion to further restrict but not stopthe flow in the lumen and to:

-   -   a) control the stimulation device in a second mode to cease the        stimulation of the wall portion to increase the flow in the        lumen; or    -   b) control the stimulation and constriction devices in the        second mode to cease the stimulation of the wall portion and        release the wall portion to restore the flow in the lumen.

In accordance with a second flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat flow in the lumen is restricted but not stopped, and controls thestimulation device to stimulate the constricted wall portion to causecontraction thereof, such that flow in the lumen is stopped. Moreprecisely, the control device may control the stimulation device in afirst mode to stimulate the constricted wall portion to further restrictbut not stop the flow in the lumen and to:

-   -   a) control the stimulation device in a second mode to cease the        stimulation of the wall portion to allow flow in the lumen; or    -   b) control the stimulation and constriction devices in the        second mode to cease the stimulation of the wall portion and        release the wall portion to restore the flow in the lumen.

In accordance with a third flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the flow in the lumen is substantially stopped, and controls thestimulation device to stimulate the constricted wall portion to causecontraction thereof, such that the flow in the lumen is completelystopped. More precisely, the control device may control the stimulationdevice in a first mode to stimulate the constricted wall portion tocompletely stop the flow in the lumen and to:

-   -   a) control the stimulation device in a second mode to cease the        stimulation of the wall portion to allow flow in the lumen; or    -   b) control the stimulation and constriction devices in the        second mode to cease the stimulation of the wall portion and        release the wall portion to restore the flow in the lumen.

For example, the third flow restriction option may be applied where thepresent invention is used for controlling fecal flow of an analincontinent patient. Thus, the restriction and stimulation devices maybe implanted on any part of the incontinent patient's large or smallintestines to serve as an artificial anal sphincter. Betweendefecations, the control device controls the constriction device togently flatten a portion of the intestines to at least almost completelystop the fecal flow in the intestines, and controls the stimulationdevice to stimulate the flattened portion to insure that the fecal flowis completely stopped. Since the control device controls the stimulationdevice to intermittently and individually stimulate the areas of thewall portion, as stated above in paragraph 0015, the risk of theimplanted constriction device injuring the intestines over time issignificantly reduced or even eliminated, and it is insured that theeffect of the stimulation is maintained over time. When the patientwants to defecate, the control device controls the constriction andstimulation devices to release the portion of the intestines and ceasethe stimulation, whereby fecal matter may pass the portion of theintestines. However, it should be noted that in some other applicationsof the present invention, for example where the invention is used forcontrolling urine flow of a urinary incontinent patient, it may sufficeto just cease the stimulation to achieve fluid flow through the organ inquestion.

Where the stimulation device stimulates the constricted wall portion tocontract, such that the flow in the lumen is stopped, the control devicesuitably controls the stimulation device to simultaneously andcyclically stimulate a first length of the constricted wall portion anda second length of the constricted wall portion, which is locateddownstream of the first length, wherein the control device controls thestimulation device to progressively stimulate the first length in theupstream direction of the lumen and to progressively stimulate thesecond length in the downstream direction of the lumen.

The control device may control the stimulation device to change thestimulation of the wall portion in response to a sensed physicalparameter of the patient or functional parameter of the apparatus. Forexample, the control device may control the stimulation device toincrease the intensity of the stimulation of the wall portion inresponse to a sensed pressure increase in the lumen, such that the flowin the lumen remains stopped. Any sensor for sensing a physicalparameter of the patient, such as a pressure in the patient's body thatrelates to the pressure in the lumen may be provided, wherein thecontrol device controls the stimulation device in response to signalsfrom the sensor. Such a sensor may for example sense the pressure in thepatient's abdomen, the pressure against the implanted constrictiondevice or the pressure on the tissue wall of the bodily organ.

For example, a pressure sensor may be applied where the presentinvention is used for controlling urine flow of a urinary incontinentpatient. Thus, the constriction and stimulation devices may be appliedon the urinary incontinent patient's urethra or urine bladder to serveas an artificial sphincter, wherein the constriction device constrictsthe urethra or urine bladder, such that the urine flow is substantiallystopped, and the stimulation device stimulates the constricted urethraor urine bladder to cause contraction thereof to completely stop theurine flow. The control device controls the stimulation device toincrease the stimulation intensity in response to signals from thepressure sensor sensing a sudden increase in the pressure in thepatient's bladder or abdominal cavity, whereby the urine flow remainsstopped and the patient maintains continence. In this manner, thepresent invention insures that the patient even is continent when he orshe sneezes or coughs, or performs other physical activity that causes asudden pressure increase in the patient's bladder/urinary tract.

In accordance with a fourth flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the flow in the lumen is stopped. More precisely, the controldevice may control the constriction device in a first mode to constrictthe constricted wall portion to stop the flow in the lumen and in asecond mode to cease the constriction of the wall portion to restoreflow in the lumen. In this case, the control device only controls thestimulation device to stimulate the wall portion when needed. A sensorfor sensing a physical parameter of the patient's body that relates tothe pressure in the lumen may be provided, wherein the control devicecontrols the stimulation device in response to signals from the sensor.Such a physical parameter may be a pressure in the patient's abdomen andthe sensor may be a pressure sensor.

For example, the fourth flow restriction option may be applied where thepresent invention is used for controlling urine flow of a urinaryincontinent patient in a manner similar to the situation described inthe foregoing paragraph 0026. However, in this example stimulation isonly applied when necessary to maintain continence, Thus, the controldevice controls the stimulation device to stimulate the urethra or urinebladder to cause contraction thereof in response to signals from thepressure sensor sensing a sudden increase in the pressure in thepatient's bladder or abdominal cavity, when the patient sneezes orcoughs, or performs other physical activity. As a result, the urine flowremains stopped and the patient maintains continence.

In some applications of the invention, the implanted constriction devicemay be designed to normally keep the patient's wall portion of the organin the constricted state. In this case, the control device may be usedwhen needed, conveniently by the patient, to control the stimulationdevice to stimulate the constricted tissue wall portion, preferablywhile adjusting the stimulation intensity, to cause contraction of thewall portion, such that the flow in the lumen is at least furtherrestricted or stopped, and to control the stimulation device to ceasethe stimulation. More precisely, the control device may:

-   -   a) control the stimulation device in a first mode to stimulate        the constricted wall portion to further restrict the flow in the        lumen, and control the stimulation device in a second mode to        cease the stimulation of the wall portion to increase the flow        in the lumen; or    -   b) control the stimulation device in a first mode to stimulate        the constricted wall portion to stop the flow in the lumen, and        control the stimulation device in a second mode to cease the        stimulation of the wall portion to allow flow in the lumen.

Either the first mode or the second mode may be temporary.

The constriction device may include a plurality of separate constrictionelements adapted to constrict any wall portions of a series of wallportions of the organ's tissue wall, respectively. The control devicemay control the constriction device to activate the constrictionelements in random or in accordance with a predetermined sequence. Inthis case, the stimulation device includes stimulation elementspositioned on the constriction elements, wherein the control devicecontrols the stimulation device to activate the stimulation elements tostimulate any wall portions of the series of wall portions constrictedby said constriction elements to contract the organ to close the organ'slumen.

Alternatively, the control device controls the constriction device toactivate the constriction elements to constrict all of the wall portionsof the series of wall portions, and controls the stimulation device toactivate the stimulation elements to stimulate any constricted wallportions in random or in accordance with a predetermined sequence toclose the organ's lumen. The design of the constriction device in theform of a plurality of separate constriction elements makes possible tocounteract growth of hard fibrosis where the constriction device isimplanted.

Movement of Fluid and/or Other Bodily Matter in Lumen

The apparatus of the invention can be used for actively moving the fluidand/or other bodily matter in the lumen of a patient's organ, asdescribed in the embodiments of the invention listed below.

1) The control device controls the constriction device to close thelumen, either at an upstream end or a downstream end of the wallportion, and then controls the constriction device to constrict theremaining part of the wall portion to move the fluid and/or other bodilymatter in the lumen.

1a) In accordance with a first alternative of the above noted embodiment(1), the control device controls the stimulation device to stimulate thewall portion as the constriction device constricts the remaining part ofthe wall portion.

1b) In accordance with a second alternative, the constriction device isadapted to constrict the wall portion to restrict but not stop the flowin the lumen. The control device controls the stimulation device tostimulate the wall portion constricted by the constriction device toclose the lumen, either at an upstream end or a downstream end of thewall portion, and simultaneously controls the constriction device toincrease the constriction of the wall portion to move the fluid and/orother bodily matter in the lumen.

2) The constriction device is adapted to constrict the wall portion torestrict or vary the flow in the lumen, and the control device controlsthe stimulation device to progressively stimulate the constricted wallportion, in the downstream or upstream direction of the lumen, to causeprogressive contraction of the wall portion to move the fluid and/orother bodily matter in the lumen.

3) The control device controls the constriction device to vary theconstriction of the different areas of the wall portion, such that thewall portion is progressively constricted in the downstream or upstreamdirection of the lumen to move the fluid and/or other bodily matter inthe lumen. The constriction device may include at least one elongatedconstriction element that extends along the wall portion, wherein thecontrol device controls the elongated constriction element toprogressively constrict the wall portion in the downstream or upstreamdirection of the lumen.

3a) In accordance with a preferred alternative of the above notedembodiment (3), the control device controls the stimulation device toprogressively stimulate the constricted wall portion to causeprogressive contraction thereof in harmony with the progressiveconstriction of the wall portion performed by the constriction device.Where the constriction device includes at least one elongatedconstriction element the control device controls the elongatedconstriction element to progressively constrict the wall portion in thedownstream or upstream direction of the lumen. Suitably, the elongatedconstriction element comprises contact surfaces dimensioned to contact alength of the wall portion, when the constriction device constricts thewall portion, and the stimulation device comprises a plurality ofstimulation elements distributed along the contact surfaces, such thatthe stimulation elements stimulate the different areas of the wallportion along the length of the wall portion, when the control devicecontrols the stimulation device to stimulate the wall portion.

4) The constriction device is adapted to constrict any one of a seriesof wall portions of the tissue wall to at least restrict the flow in thelumen. The control device controls the constriction device tosuccessively constrict the wall portions of the series of wall portionsto move the fluid and/or other bodily matter in the lumen in aperistaltic manner.

4a) In accordance with a first alternative of embodiment (4), theconstriction device includes a plurality of constriction elementsadapted to constrict the wall portions of the tissue wall, respectively.The control device controls the constriction device to activate theconstriction elements one after the other, so that the wall portions ofthe series of wall portions are successively constricted along theorgan, whereby the fluid and/or other bodily matter in the lumen ismoved.

4b) In accordance with a second alternative of embodiment (4), theconstriction device includes at least one constriction element that ismoveable along the wall of the organ to successively constrict the wallportions of the series of wall portions, wherein the control devicecontrols the constriction device to cyclically move the constrictionelement along the wall portions of the series of wall portions.Preferably, the constriction device comprises a plurality ofconstriction elements, each of which is moveable along the wall of theorgan to successively constrict the wall portions of the series of wallportions, wherein the control device controls the constriction device tocyclically move the constriction elements one after the other along thewall portions of the series of wall portions. Specifically, theconstriction device includes a rotor carrying the constriction elements,and the control device controls the rotor to rotate, such that eachconstriction element cyclically constricts the wall portions of theseries of wall portions. Each constriction element suitably comprises aroller for rolling on the wall of the organ to constrict the latter.

4c) In accordance with a preferred alternative of the above notedembodiment (4), the stimulation device stimulates any of the wallportions of the series of wall portions constricted by the constrictiondevice, to close the lumen. Where the constriction device includes atleast one constriction element, the stimulation device suitably includesat least one stimulation element positioned on the constriction elementfor stimulating the wall portion constricted by the constriction elementto close the lumen.

Where the constriction device includes a plurality of constrictionelements, the stimulation device suitably includes stimulation elementspositioned on the constriction elements for stimulating the wallportions constricted by the constriction elements to close the lumen.

5) The constriction device is adapted to constrict any one of a seriesof wall portions of the tissue wall to restrict the flow in the lumen,wherein the constriction device includes a plurality of constrictionelements adapted to constrict the wall portions of the tissue wall,respectively, and the stimulation device includes stimulation elementspositioned on the constriction elements for stimulating the wallportions constricted by the constriction elements to close the lumen.The control device controls the constriction device to activate theconstriction elements to constrict the wall portions of the series ofwall portions without completely closing the organ's lumen, and controlsthe stimulation device to activate the stimulation elements to stimulatethe wall portions one after the other, so that the wall portions of theseries of wall portions are successively contracted along the organ tomove the fluid and/or other bodily matter in the lumen of the patient'sorgan.

6) The constriction device comprises a first constriction element forconstricting the wall portion at an upstream end thereof, a secondconstriction element for constricting the wall portion at a downstreamend thereof, and a third constriction element for constricting the wallportion between the upstream and downstream ends thereof. The controldevice controls the first, second and third constriction elements toconstrict and release the wall portion independently of one another.More specifically, the control device controls the first or secondconstriction element to constrict the wall portion at the upstream ordownstream end thereof to close the lumen, and controls the thirdconstriction element to constrict the wall portion between the upstreamand downstream ends thereof, whereby the fluid and/or other bodilymatter contained in the wall portion between the upstream and downstreamends thereof is moved downstream or upstream in the lumen.

Optionally, the control device controls the stimulation device tostimulate the wall portion between the upstream and downstream endsthereof, when the third constriction element constricts the wallportion.

6a) In accordance with a first alternative, the control device controlsthe first constriction element to constrict the wall portion at theupstream end thereof to restrict the flow in the lumen and controls thestimulation device to stimulate the constricted wall portion at theupstream end to close the lumen. With the lumen closed at the upstreamend of the constricted wall portion, the control device controls thethird constriction element to constrict the wall portion between theupstream and downstream ends thereof, and optionally controls thestimulation device to simultaneously stimulate the wall portion as thelatter is constricted by the third constriction element. As a result,the fluid and/or other bodily matter contained in the wall portionbetween the upstream and downstream ends thereof is moved downstream inthe lumen.

6b) In accordance with a second alternative, the control device controlsthe second constriction element to constrict the wall portion at thedownstream end thereof to restrict the flow in the lumen and controlsthe stimulation device to stimulate the constricted wall portion at thedownstream end to close the lumen. With the lumen closed at thedownstream end of the constricted wall portion, the control devicecontrols the third constriction element to constrict the wall portionbetween the upstream and downstream ends thereof, and optionallycontrols the stimulation device to simultaneously stimulate the wallportion as the latter is constricted by the third constriction element.As a result, the fluid and/or other bodily matter contained in the wallportion between the upstream and downstream ends thereof is movedupstream in the lumen.

In any of the above noted embodiments (1) to (6b), the stimulationdevice may stimulate the wall portion with electric pulses.

Where the organ is tubular in shape, such as the small intestines, aparticularly long wall portion of the tubular organ may be surgicallyprepared to extend in zigzag with adjacent walls stitched together bytwo parallel rows of stitches and with the adjacent walls cut throughbetween the two rows of stitches. As a result, the lumen of this longwall portion of the organ can be significantly expanded. In this case,the constriction device of the apparatus of the invention is able tomove a considerably larger volume of fluid each time it constricts thelong wall portion of the organ.

The various solutions described above under the headline: “Flowrestriction” to stop the flow in the lumen of the organ may also be usedin any of the above noted embodiments (1a), (1b), (4a), (5), (6), (6a)and (6b).

Stimulation

When stimulating neural or muscular tissue there is a risk of injuringor deteriorating the tissue over time, if the stimulation is notproperly performed. The apparatus of the present invention is designedto reduce or even eliminate that risk. Thus, in accordance with thepresent invention, the control device controls the stimulation device tointermittently stimulate different areas of the wall portion of theorgan, such that at least two of the areas are stimulated at differentpoints of time that is, the stimulation is shifted from one area toanother area over time. In addition, the control device controls thestimulation device, such that an area of the different areas thatcurrently is not stimulated has time to restore substantially normalblood circulation before the stimulation device stimulates the areaagain. Furthermore, the control device controls the stimulation deviceto stimulate each area during successive time periods, wherein each timeperiod is short enough to maintain satisfactory blood circulation in thearea until the lapse of the time period. This gives the advantage thatthe apparatus of the present invention enables continuous stimulation ofthe wall portion of the organ to achieve the desired flow control, whileessentially maintaining over time the natural physical properties of theorgan without risking injuring the organ.

Also, by physically changing the places of stimulation on the organ overtime as described above it is possible to create an advantageouschanging stimulation pattern on the organ, in order to achieve a desiredflow control.

The control device may control the stimulation device to stimulate oneor more of the areas of the wall portion at a time, for example bysequentially stimulating the different areas. Furthermore, the controldevice may control the stimulation device to cyclically propagate thestimulation of the areas along the wall portion, preferably inaccordance with a determined stimulation pattern. To achieve the desiredreaction of the tissue wall during the stimulation thereof, the controldevice may control the stimulation device to, preferably cyclically,vary the intensity of the stimulation of the wall portion.

In a preferred embodiment of the invention, the control device controlsthe stimulation device to intermittently stimulate the areas of the wallportion with pulses that preferably form pulse trains. At least a firstarea and a second area of the areas of the wall portion may berepeatedly stimulated with a first pulse train and a second pulse train,respectively, such that the first and second pulse trains over time areshifted relative to each other. For example, the first area may bestimulated with the first pulse train, while the second area is notstimulated with said second pulse train, and vice versa. Alternatively,the first and second pulse trains may be shifted relative to each other,such that the first and second pulse trains at least partially overlapeach other.

The pulse trains can be configured in many different ways. Thus, thecontrol device may control the stimulation device to vary the amplitudesof the pulses of the pulse trains, the duty cycle of the individualpulses of each pulse train, the width of each pulse of the pulse trains,the length of each pulse train, the repetition frequency of the pulsesof the pulse trains, the repetition frequency of the pulse trains, thenumber of pulses of each pulse train, and/or the off time periodsbetween the pulse trains. Several pulse trains of differentconfigurations may be employed to achieve the desired effect.

In case the control device controls the stimulation device to vary theoff time periods between pulse trains that stimulate the respective areaof the wall portion, it is also possible to control each off time periodbetween pulse trains to last long enough to restore substantially normalblood circulation in the area when the latter is not stimulated duringthe off time periods.

Electric Stimulation

In accordance with a preferred embodiment of the invention, thestimulation device is an electrically powered stimulation device thatelectrically stimulates the tissue wall portion of the patient's bodilyorgan, preferably with electric pulses. This embodiment is particularlysuited for applications in which the wall portion includes muscle fibersthat react to electrical stimula. In this embodiment, the control devicecontrols the stimulation device to stimulate the wall portion withelectric pulses preferably in the form of electric pulse trains, whenthe wall portion is in the constricted state, to cause contraction ofthe wall portion. Of course, the configuration of the electric pulsetrains may be similar to the above described pulse trains and thecontrol device may control the stimulation device to electricallystimulate the different areas of the wall of the organ in the samemanner as described above.

The electric stimulation device suitably comprises at least one,preferably a plurality of electrical elements, such as electrodes, forengaging and stimulating the wall portion with electric pulses.Optionally, the electrical elements may be placed in a fixed orientationrelative to one another. The control device controls the electricstimulation device to electrically energize the electrical elements, oneat a time, or groups of electrical elements at a time. Preferably, thecontrol device controls the electric stimulation device to cyclicallyenergize each element with electric pulses. Optionally, the controldevice may control the stimulation device to energize the electricalelements, such that the electrical elements are energized one at a timein sequence, or such that a number or groups of the electrical elementsare energized at the same time. Also, groups of electrical elements maybe sequentially energized, either randomly or in accordance with apredetermined pattern.

The electrical elements may form any pattern of electrical elements.Preferably, the electrical elements form an elongate pattern ofelectrical elements, wherein the electrical elements are applicable onthe patient's wall of the organ, such that the elongate pattern ofelectrical elements extends lengthwise along the wall of the organ, andthe elements abut the respective areas of the wall portion. The elongatepattern of electrical elements may include one or more rows ofelectrical elements extending lengthwise along the wall of the organ.Each row of electrical elements may form a straight, helical or zig-zagpath of electrical elements, or any form of path. The control device maycontrol the stimulation device to successively energize the electricalelements longitudinally along the elongate pattern of electricalelements in a direction opposite to, or in the same direction as thatof, the flow in the patient's lumen.

Optionally, the control device may control the stimulation device tosuccessively energize the electrical elements from a positionsubstantially at the center of the constricted wall portion towards bothends of the elongate pattern of electrical elements. Where the lumen ofthe organ is to be kept closed for a relatively long time, the controldevice may control the stimulation device to energize the electricalelements, such that energized electrical elements form two waves ofenergized electrical elements that simultaneously advance from thecenter of the constricted wall portion in two opposite directionstowards both ends of the elongate pattern of electrical elements. Suchwaves of energized electrical elements can be repeated over and overagain without harming the organ and without moving fluid or gas in anydirection in the lumen of the organ.

The control device suitably controls the stimulation device to energizethe electrical elements, such that the electrical elements currentlyenergized form at least one group of adjacent energized electricalelements. In accordance with a first alternative, the elements in thegroup of energized electrical elements form one path of energizedelectrical elements. The path of energized electrical elements mayextend at least in part around the patient's organ. In a secondalternative, the elements of the group of energized electrical elementsmay form two paths of energized electrical elements extending on mutualsides of the patient's organ, preferably substantially transverse to theflow direction in the lumen of the organ. In a third alternative, theelements of the group of energized electrical elements may form morethan two paths of energized electrical elements extending on differentsides of the patient's organ, preferably substantially transverse to theflow direction in the patient's lumen.

In accordance with a preferred embodiment of the invention, theelectrical elements form a plurality of groups of elements, wherein thegroups form a series of groups extending along the patient's organ inthe flow direction in the patient's lumen. The electrical elements ofeach group of electrical elements may form a path of elements extendingat least in part around the patient's organ. In a first alternative, theelectrical elements of each group of electrical elements may form morethan two paths of elements extending on different sides of the patient'sorgan, preferably substantially transverse to the flow direction in thepatient's lumen. The control device may control the stimulation deviceto energize the groups of electrical elements in the series of groups inrandom, or in accordance with a predetermined pattern. Alternatively,the control device may control the stimulation device to successivelyenergize the groups of electrical elements in the series of groups in adirection opposite to, or in the same direction as that of, the flow inthe patient's lumen, or in both said directions starting from a positionsubstantially at the center of the constricted wall portion. Forexample, groups of energized electrical elements may form advancingwaves of energized electrical elements, as described above; that is, thecontrol device may control the stimulation device to energize the groupsof electrical elements, such that energized electrical elements form twowaves of energized electrical elements that simultaneously advance fromthe center of the constricted wall portion in two opposite directionstowards both ends of the elongate pattern of electrical elements.

A structure may be provided for holding the electrical elements in afixed orientation. Although the structure may be separate from theconstriction device, it is preferable that the structure is integratedin the constriction device, which is a practical design and facilitatesimplantation of the constriction and stimulation devices. Where theelectrical elements form an elongate pattern of electrical elements, thestructure may be applicable on the patient's organ such that theelongate pattern of electrical elements extends along the organ in thesame direction as that of the flow in the patient's lumen and theelements abut the respective areas of the wall portion of the organ.

Thermal Stimulation

In another embodiment of the invention, the stimulation device thermallystimulates the wall portion of the organ. Thus, the control device maycontrol the stimulation device to cool the wall portion, when the wallportion is constricted, to cause contraction of the wall portion. Forexample, the constriction device may constrict the wall portion to atleast restrict the flow in the lumen, and the control device may controlthe stimulation device to cool the constricted wall portion to causecontraction thereof, such that the flow in the lumen is at least furtherrestricted, or further restricted but not stopped, or stopped.Alternatively, the control device may control the stimulation device toheat the wall portion, when the wall portion is constricted andcontracted, to cause expansion of the wall portion. Where the wallportion includes a blood vessel, the control device may control thestimulation device to cool the blood vessel to cause contractionthereof, or heat the blood vessel to cause expansion thereof. Whereapplicable, thermal stimulation may be practised in any of theembodiments of the present invention, and the thermal stimulation may becontrolled in response to various sensors, for example strain, motion orpressure sensors.

Sensor Controlled Constriction and/or Stimulation Device

As mentioned above, the apparatus may comprise at least one implantablesensor, wherein the control device controls the constriction deviceand/or the stimulation device in response to signals from the sensor.Generally, the sensor directly or indirectly senses at least onephysical parameter of the patient, or at least one functional parameterof the apparatus, or at least one functional parameter of a medicalimplant in the patient.

Many different kinds of sensor for sensing physical parameters may beused. For example motion sensors for sensing organ motion, i.e. naturalcontractions, such as stomach or intestinal contractions, pressuresensors for sensing pressure in the organ, strain sensors for sensingstrain of the organ, flow sensors for sensing fluid flow in the lumen ofthe organ, spectro-photometrical sensors, Ph-sensors for sensing acidityor alkalinity of the fluid in the lumen of the organ, oxygen-sensorssensors for sensing the oxygen content of the fluid in the lumen of theorgan, or sensors for sensing the distribution of the stimulation on thestimulated organ. Any conceivable sensors for sensing any other kind ofuseful physical parameter may be used.

Many different kinds of sensors that sense functional parameters of theapparatus may also be used for the control of the constriction deviceand/or, the stimulation device. For example sensors for sensing electricparameters of implanted electric components of the apparatus, or sensorsfor sensing the performance of implanted motors of the apparatus.

The sensor may comprise a pressure sensor for sensing as the physicalparameter a pressure in the patient's body that relates to the pressurein the lumen of the patient's bodily organ, wherein the control devicecontrols the constriction device and/or stimulation device to change theconstriction of the patient's wall portion in response to the pressuresensor sensing a predetermined value of measured pressure.

Alternatively, or in combination with the pressure sensor, a positionsensor may be provided for sensing as the physical parameter theorientation of the patient with respect to the horizontal. The positionsensor may be a biocompatible version of what is shown in U.S. Pat. Nos.4,942,668 and 5,900,909. For example, the control device may control theconstriction device and/or stimulation device to change the constrictionof the patient's wall portion in response to the position sensor sensingthat the patient has assumed a substantially horizontal orientation,i.e. that the patient is lying down.

The above described sensors may be used in any of the embodiments of theinvention, where applicable.

The control device may control the constriction device and/orstimulation device to change the constriction of the patient's wallportion in response to the time of day. For that purpose the controldevice may include a clock mechanism for controlling the constrictiondevice and/or stimulation device to change the constriction of thepatient's wall portion to increase or decrease the influence on the flowin the lumen during different time periods of the day. In case a sensorof any of the above-described types for sensing a physical or functionalparameter is provided, either the clock mechanism is used forcontrolling the constriction device and/or stimulation device providedthat the parameter sensed by the sensor does not override the clockmechanism, or the sensor is used for controlling the constriction deviceand/or stimulation device provided that the clock mechanism does notoverride the sensor. Suitably, the control device produces anindication, such as a sound signal or displayed information, in responseto signals from the sensor.

The control device may comprise an implantable internal control unitthat directly controls the constriction device and/or stimulation devicein response to signals from the sensor. The control device may furthercomprise a wireless remote control adapted to set control parameters ofthe internal control unit from outside the patient without mechanicallypenetrating the patient. At least one of the control parameters, whichis settable by the wireless remote control, is the physical orfunctional parameter. Suitably, the internal control unit includes theabove mentioned clock mechanism, wherein the wireless remote controlalso is adapted to set the clock mechanism.

Alternatively, the control device may comprise an external control unitoutside the patient's body for controlling the constriction deviceand/or stimulation device in response to signals from the sensor.

Adjustable Constriction Device

In several alternative embodiments of the invention, the constrictiondevice is adjustable. In these embodiments, there is an operation devicefor operating the adjustable constriction device to change theconstriction of the patient's tissue wall portion, and the constrictionand stimulation devices form a constriction/stimulation unit.Preferably, the constriction and stimulation devices of theconstriction/stimulation unit are integrated in a single piece suitablefor implantation. The constriction device of the unit comprises contactsurfaces dimensioned to contact a length of a tissue wall portion of apatient's organ, and the stimulation device of the unit comprises aplurality of stimulation elements provided on and distributed along thecontact surfaces. When the control device controls the stimulationdevice to stimulate the wall portion, the stimulation elements stimulatedifferent areas of the wall portion along the length of the wallportion. The stimulation elements preferably comprise electric elements,as described above, for stimulating the wall portion with electricpulses. However, in most applications of the present invention, otherkinds of stimulations, such as thermal stimulation, could be suitable toemploy.

The operation device operates the adjustable constriction device of theconstriction/stimulation unit in a manner that depends on the design ofthe constriction device, as will be explained by the following examplesof embodiments.

1) The constriction device comprises at least two elongated clampingelements having the contact surfaces and extending along the wallportion on different sides of the organ, and the operation deviceoperates the clamping elements to clamp the wall portion between theclamping elements to constrict the wall portion of the organ.

2) The constriction device comprises one elongate clamping elementhaving the contact surfaces and extending along the wall portion on oneside of the organ, and the operation device operates the clampingelement to clamp the wall portion between the clamping element and thebone or tissue of the patient to constrict the wall portion.

3) The constriction device comprises at least two engagement elementshaving the contact surfaces and positioned on different sides of theorgan, and the operation device rotates the engagement elements, suchthat the engagement elements engage and constrict the wall portion ofthe organ.

4) The constriction device comprises at least two articulated clampingelements having the contact surfaces and positioned on different sidesof the organ, and the operation device moves the clamping elementstowards each other to clamp the wall portion of the organ between theclamping elements, to constrict the wall portion.

5) The constriction device comprises at least two separate clampingelements having the contact surfaces, at least one of the clampingelements being pivoted, such that it may turn in a plane in which theloop of the constriction member extends, and the operation device turnsthe pivoted clamping element to change the size of the constrictionopening.

6) The constriction device comprises at least one elongated constrictionmember having the contact surfaces, and forming means for forming theconstriction member into at least a substantially closed loop around theorgan, wherein the loop defines a constriction opening. The operationdevice operates the constriction member in the loop to change the sizeof the constriction opening.

6a) The elongated constriction member comprises a belt having thecontact surfaces, and the operation device operates the belt to changethe longitudinal extension of the belt in the loop to change the size ofthe constriction opening. The forming means may form the constrictionmember or belt into a loop having at least one predetermined size.

6b) The elongated constriction member is operable to change the size ofthe constriction opening, such that the outer circumferentialconfinement surface of the constriction device is changed, or,alternatively, is unchanged.

6c) The elongated constriction member is elastic and varies in thicknessas seen in a cross-section there through, and is operable to turn aroundthe longitudinal extension of the constriction member.

6d) The elongated constriction member comprises two substantially orpartly semi-circular frame elements having the contact surfaces andhinged together, such that the semi-circular elements are swingablerelative to each other from a fully open state in which theysubstantially or partly form a circle to a fully folded state in whichthey substantially form a semi-circle.

7) The constriction device is adapted to bend the wall portion of theorgan to constrict the latter.

In the above noted embodiments (1) to (7), it is important that theconstriction device is designed to constrict said length of the tissuewall portion of the patient's organ. For this purpose, the constrictiondevice may include two or more of the described constrictionelements/members to be applied in a row along said length of the wallportion, wherein said row extends in the direction of flow in the lumenof the organ. Preferably, such constriction elements/members arenon-inflatable and mechanically operable or adjustable.

In the above noted embodiments (1) to (7), the operation device mayeither mechanically or hydraulically adjust the constriction device ofthe constriction/stimulation unit. Also, the operation device maycomprise an electrically powered operation device for operating theconstriction device. For many applications of the present invention, theoperation device suitably operates the constriction device, such thatthe through-flow area of the lumen assumes a size in the constrictedstate that enables the stimulation device to contract the wall portionsuch that the flow in the lumen is stopped.

Mechanical Operation

Where the operation device mechanically operates the constriction deviceof the constriction/stimulation unit, it may be non-inflatable.Furthermore, the operation device may comprise a servo system, which mayinclude a gearbox. The term “servo system” encompasses the normaldefinition of a servo mechanism, i.e., an automatic device that controlslarge amounts of power by means of very small amounts of power, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a weak force acting on a moving element having a longstroke into a strong force acting on another moving element having ashort stroke. Preferably, the operation device operates the constrictiondevice in a non-magnetic and/or non-manual manner. A motor may beoperatively connected to the operation device. The operation device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function.

Hydraulic Operation

Where the operation device hydraulically operates the constrictiondevice of the constriction/stimulation unit, it includes hydraulic meansfor adjusting the constriction device.

In an embodiment of the invention, the hydraulic means comprises areservoir and an expandable/contractible cavity in the constrictiondevice, wherein the operation device distributes hydraulic fluid fromthe reservoir to expand the cavity, and distributes hydraulic fluid fromthe cavity to the reservoir to contract the cavity. The cavity may bedefined by a balloon of the constriction device that abuts the tissuewall portion of the patient's organ, so that the patient's wall portionis constricted upon expansion of the cavity and released uponcontraction of the cavity.

Alternatively, the cavity may be defined by a bellows that displaces arelatively large contraction element of the constriction device, forexample a large balloon that abuts the wall portion, so that thepatient's wall portion is constricted upon contraction of the bellowsand released upon expansion of the bellows. Thus, a relatively smalladdition of hydraulic fluid to the bellows causes a relatively largeincrease in the constriction of the wall portion. Such a bellows mayalso be replaced by a suitably designed piston/cylinder mechanism.

Where the hydraulic means comprises a cavity in the constriction device,the apparatus of the invention can be designed in accordance with theoptions listed below.

1) The reservoir comprises first and second wall portions, and theoperation device displaces the first and second wall portions relativeto each other to change the volume of the reservoir, such that fluid isdistributed from the reservoir to the cavity, or from the cavity to thereservoir.

-   -   1a) The first and second wall portions of the reservoir are        displaceable relative to each other by at least one of a        magnetic device, a hydraulic device or an electric control        device.

2) The operation device comprises a pump for pumping fluid between thereservoir and the cavity.

-   -   2a) The pump comprises a first activation member for activating        the pump to pump fluid from the reservoir to the cavity and a        second activation member for activating the pump to pump fluid        from the cavity to the reservoir.        -   2a1) The first and second activation members are operable by            manual manipulation thereof.        -   2a2) At least one of the activation members operates when            subjected to an external predetermined pressure.        -   2a3) At least one of the first and second activating members            is operable by magnetic means, hydraulic means, or electric            control means.    -   2b) The apparatus comprises a fluid conduit between the pump and        the cavity, wherein the reservoir forms part of the conduit. The        conduit and pump are devoid of any non-return valve. The        reservoir forms a fluid chamber with a variable volume, and the        pump distributes fluid from the chamber to the cavity by a        reduction in the volume of the chamber and withdraws fluid from        the cavity by an expansion of the volume of the chamber. The        apparatus further comprises a motor for driving the pump,        wherein the pump comprises a movable wall of the reservoir for        changing the volume of the chamber.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, the cavitycan be exchanged by a cylinder/piston mechanism for adjusting theconstriction device. In this case, the operation device distributeshydraulic fluid between the reservoir and the cylinder/piston mechanismto adjust the constriction device.

In a special embodiment of the invention, the operation device comprisesa reverse servo operatively connected to the hydraulic means. The term“reverse servo” is to be understood as a mechanism that transfers astrong force acting on a moving element having a short stroke into aweak force acting on another moving element having a long stroke; i.e.,the reverse function of a normal servo mechanism. Thus, minor changes inthe amount of fluid in a smaller reservoir could be transferred by thereverse servo into major changes in the amount of fluid in a largerreservoir. The reverse servo is particularly suited for manual operationthereof.

Preferably, the reverse servo comprises an expandable servo reservoircontaining servo fluid and a fluid supply reservoir hydraulicallyconnected to the servo reservoir to form a closed conduit system for theservo fluid. The expandable servo reservoir has first and second wallportions, which are displaceable relative to each other in response to achange in the volume of the expandable servo reservoir.

In accordance with a first alternative, the first and second wallportions of the servo reservoir are operatively connected to thehydraulic means. The reverse servo distributes fluid between the fluidsupply reservoir and the expandable servo reservoir to change the volumeof the servo reservoir, whereby the hydraulic means is operated toadjust the constriction device.

In accordance with a second alternative, there is provided animplantable main reservoir containing a predetermined amount ofhydraulic fluid, wherein the reverse servo is operable to distributehydraulic fluid between the main reservoir and the hydraulic means toadjust the constriction device. More specifically, the main reservoir isprovided with first and second wall portions operatively connected tothe first and second wall portions of the expandable servo reservoir,such that the volume of the main reservoir is changed when the volume ofthe expandable servo reservoir is changed. Thus, when the reverse servodistributes servo fluid between the fluid supply reservoir and theexpandable servo reservoir to change the volume of the main reservoir,hydraulic fluid is distributed from the main reservoir to the hydraulicmeans, or from the hydraulic means to the main reservoir.Advantageously, the servo and main reservoirs are dimensioned, such thatwhen the volume of the servo reservoir is changed by a relatively smallamount of servo fluid, the volume of the main reservoir is changed by arelatively large amount of hydraulic fluid.

In both of the above-described alternatives, the fluid supply reservoirmay have first and second wall portions, which are displaceable relativeto each other to change the volume of the fluid supply reservoir todistribute servo fluid between the fluid supply reservoir and theexpandable servo reservoir. The first and second wall portions of thefluid supply reservoir may be displaceable relative to each other bymanual manipulation, a magnetic device, a hydraulic device, or anelectric control device to change the volume of the fluid supplyreservoir to distribute servo fluid between the fluid supply reservoirand the expandable servo reservoir.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, or inembodiments where the hydraulic means comprises a hydraulically operablemechanical construction, the operation device may include the reverseservo described above. In a further embodiment of the invention, thehydraulic means include first and second hydraulically interconnectedexpandable/contractible reservoirs. The first reservoir is operativelyconnected to the constriction device, such that the constriction devicechanges the constriction of the patient's wall portion upon expansion orcontraction of the first reservoir. By changing the volume of the secondreservoir hydraulic fluid is distributed between the two reservoirs, sothat the first reservoir is either expanded or contracted. Thisembodiment requires no non-return valve in the fluid communicationconduits between the two reservoirs, which is beneficial to long-termoperation of the hydraulic means.

Alternatively, the hydraulic means may include first and secondhydraulically interconnected piston/cylinder mechanisms instead of thefirst and second reservoirs described above. The first piston/cylindermechanism is operatively connected to the constriction device, such thatthe constriction device changes the constriction of the patient's wallportion upon operation of the first piston/cylinder mechanism. Byoperating the second piston/cylinder mechanism hydraulic fluid isdistributed between the two piston/cylinder mechanisms, so that thefirst piston/cylinder mechanism adjusts the constriction device.

Where the constriction device does not include anexpandable/contractible cavity, the constriction device may comprise atleast two elongated clamping elements having the above-mentioned contactsurfaces and extending along the wall portion on different sides of theorgan. The hydraulic means, which may include the reverse servodescribed above, hydraulically moves the elongated clamping elementstowards the wall portion to constrict the wall portion. For example, theconstriction device may have hydraulic chambers in which the clampingelements slide back and forth, and the hydraulic means may also includea pump and an implantable reservoir containing hydraulic fluid. The pumpdistributes hydraulic fluid from the reservoir to the chambers to movethe clamping elements against the wall portion, and distributeshydraulic fluid from the chambers to the reservoir to move the clampingelements away from the wall portion.

Design of Control Device

The control device suitably controls the constriction/stimulation unitfrom outside the patient's body. Preferably, the control device isoperable by the patient. For example, the control device may comprise amanually operable switch for switching on and off theconstriction/stimulation unit, wherein the switch is adapted forsubcutaneous implantation in the patient to be manually or magneticallyoperated from outside the patient's body. Alternatively, the controldevice may comprise a hand-held wireless remote control, which isconveniently operable by the patient to switch on and off theconstriction/stimulation unit. The wireless remote control may also bedesigned for application on the patient's body like a wristwatch. Such awristwatch type of remote control may emit a control signal that followsthe patient's body to implanted signal responsive means of theapparatus.

Where the control device wirelessly controls theconstriction/stimulation unit from outside the patient's body, thewireless control function is preferably performed in a non-magneticmanner, i.e., the control device controls the constriction device of theconstriction/stimulation unit in a non-magnetic manner. The patient mayuse the remote control to control the constriction/stimulation unit toadjust the stimulation intensity and/or adjust the constriction of thewall portion. The wireless remote control may comprise at least oneexternal signal transmitter or transceiver and at least one internalsignal receiver or transceiver implantable in the patient.

The wireless remote control preferably transmits at least one wirelesscontrol signal for controlling the constriction/stimulation unit. Thecontrol signal may comprise a frequency, amplitude, phase modulatedsignal or a combination thereof, and may be an analogue or a digitalsignal, or a combination of an analogue and digital signal. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analogue control signal. Also the carrier signal maycomprise digital, analogue or a combination of digital and analoguesignals.

Any of the above control signals may comprise wave signals, for examplea sound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radiowave signal, an x-ray radiation signal or a gamma radiation signal.Alternatively, the control signal may comprise an electric or magneticfield, or a combined electric and magnetic field.

As mentioned above, the control signal may follow the patient's body toimplanted signal responsive means of the apparatus.

The control device may include a programmable internal control unit,such as a microprocessor, implantable in the patient for controlling theconstriction/stimulation unit. The control device may further include anexternal control unit intended to be outside the patient's body, whereinthe internal control unit is programmable by the external control unit.For example, the internal control unit may be programmable forcontrolling the constriction/stimulation unit over time, suitably inaccordance with an activity schedule program. The apparatus of theinvention may comprise an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator, wherein the internal communicator feeds data related tothe constriction/stimulation unit back to the external data communicatoror the external data communicator feeds data to the internal datacommunicator.

Source of Energy

The present invention also presents a solution for supplying energy foruse in connection with the operation of the constriction/stimulationunit. Thus, in a broad sense, the present invention provides anapparatus for controlling a flow of fluid and/or other bodily matter ina lumen formed by a tissue wall of a patient's organ, wherein theapparatus comprises an implantable constriction device for gentlyconstricting a portion of the tissue wall to influence the flow in thelumen, a stimulation device for intermittently and individuallystimulating different areas of the wall portion, as the constrictiondevice constricts the wall portion, to cause contraction of the wallportion to further influence the flow in the lumen, wherein theconstriction and stimulation devices form an operableconstriction/stimulation unit, a source of energy, and a control deviceoperable from outside the patient's body to control the source of energyto release energy for use in connection with the operation of theconstriction/stimulation unit. In a simple form of the invention, thesource of energy, such as a battery or accumulator, is implantable inthe patient's body.

Transmission of Wireless Energy

In a more sophisticated form of the invention, which is preferable, thesource of energy is external to the patient's body and the controldevice controls the external source of energy to release wirelessenergy. In this sophisticated form of the invention, the apparatuscomprises an energy-transmission device that transmits the releasedwireless energy from outside the patient's body to inside the patient'sbody. Among many things the wireless energy may comprise electromagneticenergy, an electric field, an electromagnetic field or a magnetic field,or a combination thereof, or electromagnetic waves. Theenergy-transmission device may transmit wireless energy for direct usein connection with the operation of the constriction/stimulation unit,as the wireless energy is being transmitted. For example, where anelectric motor or pump operates the constriction device, wireless energyin the form of a magnetic or an electromagnetic field may be used fordirect power of the motor or pump.

Thus, the motor or pump is running directly during transmission of thewireless energy. This may be achieved in two different ways: a) using atransforming device implanted in the patient to transform the wirelessenergy into energy of a different form, preferably electric energy, andpowering the motor or pump with the transformed energy, or b) using thewirelessly transmitted energy to directly power the motor or pump.Preferably wireless energy in the form of an electromagnetic or magneticfield is used to directly influence specific components of the motor orpump to create kinetic energy for driving the motor or pump. Suchcomponents may include coils integrated in the motor or pump, ormaterials influenced by magnetic fields, or permanent magnets, whereinthe magnetic or electromagnetic field influences the coils to generate acurrent for driving the motor or pump, or influences the material orpermanent magnets to create kinetic energy for driving the motor orpump.

Preferably, the energy-transmission device transmits energy by at leastone wireless signal, suitably a wave signal. The wave signal maycomprise an electromagnetic wave signal including one of an infraredlight signal, a visible light signal, an ultra violet light signal, alaser signal, a microwave signal, a radio wave signal, an x-rayradiation signal, and a gamma radiation signal. Alternatively, the wavesignal may comprise a sound or ultrasound wave signal. The wirelesssignal may be a digital or analogue signal, or a combination of adigital and analogue signal.

Transforming Wireless Energy

In accordance with a particular embodiment of the invention, animplantable energy-transforming device is provided for transformingwireless energy of a first form transmitted by the energy-transmissiondevice into energy of a second form, which typically is different fromthe energy of the first form. The constriction/stimulation unit isoperable in response to the energy of the second form. For example, thewireless energy of the first form may comprise sound waves, whereas theenergy of the second form may comprise electric energy. In this case,the energy-transforming device may include a piezo-electric element fortransforming the sound waves into electric energy. Optionally, one ofthe energy of the first form and the energy of the second form maycomprise magnetic energy, kinetic energy, sound energy, chemical energy,radiant energy, electromagnetic energy, photo energy, nuclear energy orthermal energy. Preferably, one of the energy of the first form and theenergy of the second form is non-magnetic, non-kinetic, non-chemical,non-sonic, non-nuclear or non-thermal.

The energy-transforming device may function differently from or similarto the energy-transmission device. In a special embodiment, theenergy-transforming device comprises at least one element, such as atleast one semiconductor, having a positive region and a negative region,when exposed to the energy of the first form transmitted by theenergy-transmission device, wherein the element is capable of creatingan energy field between the positive and negative regions, and theenergy field produces the energy of the second form. More specifically,the element may comprise an electrical junction element, which iscapable of inducing an electric field between the positive and negativeregions when exposed to the energy of the first form transmitted by theenergy-transmission device, whereby the energy of the second formcomprises electric energy.

The energy-transforming device may transform the energy of the firstform directly or indirectly into the energy of the second form. Animplantable motor or pump for operating the constriction device of theconstriction/stimulation unit may be provided, wherein the motor or pumpis powered by the energy of the second form. The constriction device maybe operable to perform at least one reversible, function and the motormay be capable of reversing the function. For example, the controldevice may shift polarity of the energy of the second form to reversethe motor.

The energy-transforming device may directly power the motor or pump withthe transformed energy, as the energy of the second form is beingtransformed from the energy of the first form. Preferably, theenergy-transforming device directly operates theconstriction/stimulation unit with the energy of the second form in anon-magnetic, non-thermal or non-mechanical manner.

Normally, the constriction/stimulation unit comprises electriccomponents that are energized with electrical energy. Other implantableelectric components of the apparatus may be at least one voltage levelguard or at least one constant current guard. Therefore, theenergy-transforming device may transform the energy of the first forminto a direct current or pulsating direct current, or a combination of adirect current and pulsating direct current. Alternatively, theenergy-transforming device may transform the energy of the first forminto an alternating current or a combination of a direct and alternatingcurrent.

The apparatus of the invention may comprise an internal source of energyimplantable in the patient for supplying energy for the operation of theconstriction/stimulation unit. The apparatus may further comprise animplantable switch operable to switch from an “off” mode, in which theinternal source of energy is not in use, to an “on” mode, in which theinternal source of energy supplies energy for the operation of theconstriction/stimulation unit, and/or for energizing implantedelectronic components of the apparatus. The switch may be operable bythe energy of the first form transmitted by the energy-transmissiondevice or by the energy of the second form supplied by theenergy-transforming device. The described switch arrangement reducespower consumption of the apparatus between operations.

The internal source of energy may store the energy of the second formsupplied by the energy-transforming device. In this case, the internalsource of energy suitably comprises an accumulator, such as at least onecapacitor or at least one rechargeable battery, or a combination of atleast one capacitor and at least one rechargeable battery. Where theinternal source of energy is a rechargeable battery it may be chargedonly at times convenient for the patient, for example when the patientis sleeping. Alternatively, the internal source of energy may supplyenergy for the operation of the constriction/stimulation unit but not beused for storing the energy of the second form. In this alternative, theinternal source of energy may be a battery and the switch describedabove may or may not be provided.

Suitably, the apparatus of the invention comprises an implantablestabilizer for stabilizing the energy of the second form. Where theenergy of the second form is electric energy the stabilizer suitablycomprises at least one capacitor.

The energy-transforming device may be designed for implantationsubcutaneously in the abdomen, thorax or cephalic region of the patient.Alternatively, it may be designed for implantation in an orifice of thepatients body and under the mucosa or intramuscularly outside the mucosaof the orifice.

Although the constriction/stimulation unit in the embodiments describedabove is designed as a single piece, which is most practical forimplantation, it should be noted that as an alternative the constrictiondevice and stimulation device could be designed as separate pieces. Anyone of the constriction and stimulation units described above mayalternatively be replaced by two or more separateconstriction/stimulation elements, which are controlled independently ofone another.

The above-described apparatus of the invention is suited for treatingdysfunctions of an organ of a human being or animal. For example, fortreating urinary and anal incontinence, constipation and impotence. Theapparatus of the invention is also suited for treating obesity orgallstone troubles, and for controlling blood flow in a blood vessel orthe release of eggs into a female's uterus.

Where the apparatus is used for controlling the food flow through thestomach of a patient, the apparatus comprises an implantableconstriction device for gently constricting at least one portion of thetissue wall of the patient's stomach to influence the food flow in thestomach, a stimulation device for stimulating the wall portion of thetissue wall, and a control device for controlling said stimulationdevice to stimulate the wall portion, as said constriction deviceconstricts the wall portion, to cause contraction of the wall portion tofurther influence the food flow in the stomach.

Where the apparatus is used for controlling the flow of intestinalcontents in the intestines of a patient, the apparatus comprises animplantable constriction device for gently constricting at least oneportion of the tissue wall of the patient's intestines to influence theflow of intestinal contents in the intestines, a stimulation device forstimulating the wall portion of the tissue wall, and a control devicefor controlling said stimulation device to stimulate the wall portion,as said constriction device constricts the wall portion, to causecontraction of the wall portion to further influence the flow ofintestinal contents in the intestines.

Where the apparatus is used for controlling the flow of urine in theurethra or urine bladder of a patient, the apparatus comprises animplantable constriction device for gently constricting at least oneportion of the tissue wall of the patient's urethra or urine bladder toinfluence the urine flow in the urethra or urine bladder, a stimulationdevice for stimulating the wall portion of the tissue wall, and acontrol device for controlling said stimulation device to stimulate thewall portion, as said constriction device constricts the wall portion,to cause contraction of the wall portion to further influence the urineflow in the urethra or urine bladder.

Where the apparatus is used as an impotence treatment apparatus, itcomprises a constriction device implantable in a male impotent patientfor gently constricting at least one penile portion of the patient'snormal penile tissue or the prolongation thereof, an implantablestimulation device for stimulating the penile portion, and a controldevice for controlling said stimulation device to stimulate the penileportion, as said constriction device constricts the penile portion, tocause contraction of the penile portion to restrict the blood flowleaving the penis to achieve erection. The term “normal penile tissue”is to be understood as excluding implanted tissue. Thus, the normalpenile tissue includes one or both of the corpora cavernosa and thecorpus spongiosum. The term “prolongation thereof” includes thebulbospongious and adjacent area.

Alternatively, the impotence treatment apparatus comprises aconstriction device implantable in a male impotent patient for gentlyconstricting at least one penile portion of the patient's normal peniletissue or the prolongation thereof to restrict the blood flow leavingthe penis, an implantable stimulation device for stimulating the penileportion as said constriction device constricts the penile portion, and acontrol device for controlling said stimulation device to stimulate thepenile portion, as said constriction device constricts the penileportion, to cause contraction of the penile portion to further restrictthe blood flow leaving the penis to achieve erection.

Alternatively, impotence treatment apparatus comprises a stimulationdevice implantable in a male impotent patient for stimulating at leastone penile portion of the patient's normal penile tissue or theprolongation thereof, and a control device for controlling saidstimulation device to stimulate the penile portion to cause contractionthereof to restrict the blood flow leaving the penis to achieveerection.

Where the apparatus is used for controlling the blood flow in a bloodvessel of a patient, the apparatus comprises an implantable constrictiondevice for gently constricting at least one portion of the tissue wallof the blood vessel to influence the blood flow in the blood vessel, astimulation device for stimulating the tissue wall portion, and acontrol device for controlling said stimulation device to stimulate thetissue wall portion as said constriction device constricts the tissuewall portion to cause contraction of the tissue wall portion to furtherinfluence the blood flow in the blood vessel.

Where the a apparatus is used for controlling the flow of eggs into theuterus of a female, the apparatus comprises an implantable constrictiondevice for constricting each one of the female's uterine tubes torestrict the passageway thereof, and a control device for controllingsaid constriction device to constrict the uterine tube such that an eggappearing in the passageway of the uterine tube is prevented fromentering the uterine cavity, and to release the uterine tube such thatan egg existing in the passageway of the uterine tube is allowed toenter the uterine cavity. The constriction device may gently constrictat least one portion of the tissue wall of the uterine tube to restrictthe passageway thereof, and an implantable stimulation device may beprovided for stimulating the tissue wall portion, wherein the controldevice controls said stimulation device to stimulate the tissue wallportion, as said constriction device constricts the tissue wall portion,to cause contraction of the tissue wall portion to further restrict thepassageway of the uterine tube.

Alternatively, the egg flow control apparatus comprises an implantableconstriction device for gently constricting at least one portion of thetissue wall of each one of the female's uterine tubes to restrict thepassageway thereof, a stimulation device for stimulating the tissue wallportion of the uterine tube, and a control device for controlling saidstimulation device to stimulate the tissue wall portion, as saidconstriction device constricts the tissue wall portion, to causecontraction of the tissue wall portion to further restrict thepassageway of the uterine tube to prevent an egg existing in the uterinetube from entering the uterine cavity.

Alternatively, the egg flow control apparatus comprises an implantablestimulation device for stimulating a portion of the tissue wall of eachone of the female's uterine tubes, and a control device for controllingsaid stimulation device to stimulate the tissue wall portion of theuterine tube to cause contraction of the tissue wall portion, such thatthe passageway of the uterine tube is restricted to prevent an eggappearing in the uterine tube from entering the uterine cavity, and tocease stimulating the tissue wall portion of the uterine tube to allowan egg existing in the passageway of the uterine tube to enter theuterine cavity.

Where the apparatus is used for controlling the flow of gallstones in apatient suffering from gallstone trouble, the apparatus comprises animplantable stimulation device for stimulating a portion of the tissuewall of the patient's cystic, hepatic or bile duct, and a control devicefor controlling said stimulation device to progressively stimulate thetissue wall portion to cause progressive contraction of the tissue wallportion to move one or more gallstones appearing in the duct in thedirection towards the duodenum.

The present invention also provides a method for using an apparatus asdescribed above to control a flow of fluid and/or other bodily matter ina lumen formed by a tissue wall of a patient's organ, the methodcomprising:

-   -   providing a wireless remote control adapted to control the        constriction device and/or stimulation device from outside the        patient's body, and    -   operating the wireless remote control by the patient, when the        patient wants to influence the flow of fluid and/or other bodily        matter in the lumen.

The present invention also provides a method for controlling a flow offluid and/or other bodily matter in a lumen formed by a tissue wall of apatient's organ, the method comprising:

-   -   a) gently constricting at least one portion of the tissue wall        to influence the flow in the lumen, and    -   b) stimulating the constricted wall portion to cause contraction        of the wall portion to further influence the flow in the lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A, 1B, 1C, 1D and 1E schematically illustrate different states ofoperation of a general embodiment of an apparatus according to thepresent invention.

FIGS. 1F, 1G and 1H illustrate different states of operation of amodification of the general embodiment.

FIGS. 1I, 1K and 1L illustrate an alternative mode of operation of themodification of the general embodiment.

FIG. 2 is a longitudinal cross-section of a preferred embodiment of theapparatus according to the invention including a constriction device andan electric stimulation device.

FIG. 3 is a cross-section along line III-III in FIG. 2.

FIG. 4 is the same cross-section shown in FIG. 3, but with the apparatusin a different state of operation.

FIGS. 5A, 5B and 5C are cross-sections of the embodiment of FIG. 2showing different states of operations with the apparatus applied on atissue wall of a patient's organ.

FIGS. 6A, 6B and 6C are cross-sections of a modification of theembodiment of FIG. 2 showing different states of operations with theapparatus applied on a tissue wall of a patient's organ.

FIGS. 7A and 7B show different steps of an electric stimulation modeperformed by the apparatus of FIG. 2, while the apparatus isconstricting a tissue wall of a patient's organ.

FIG. 8A is a pulse/time diagram showing electric stimulation pulsesgenerated by the apparatus of the invention for stimulating a tissuewall of a patient's organ.

FIG. 8B is pulse/time diagram showing a modification of the electricstimulation shown in FIG. 8A, in which pulses of mixed frequenciesand/or amplitudes are employed.

FIGS. 9A and 9B show two pulse/time diagrams, respectively, representingelectric stimulation of two different areas of the tissue wall withpulses forming pulse trains.

FIGS. 10A and 10B show the pulse/time diagrams of FIGS. 9A and 9B withmodified pulse trains.

FIG. 11A is a longitudinal cross-section of an embodiment of theapparatus of the invention including a thermal stimulation device,wherein the apparatus is constricting a tissue wall of a patient'sorgan.

FIG. 11B is the same embodiment of FIG. 11A with the thermal stimulationdevice activated.

FIG. 12A is a schematic view of hydraulic operation means suited foroperating the constriction device of the embodiments of FIGS. 2-11.

FIG. 12B shows the embodiment of FIG. 12A with the constriction deviceconstricting a tissue wall of a patient's organ.

FIG. 13A is a schematic view of mechanical operation means suited foroperating the constriction device of the embodiments of FIGS. 2-11.

FIG. 13B shows the embodiment of FIG. 13A with the constriction deviceconstricting a tissue wall of a patient's organ.

FIG. 13C shows a modification of the embodiment of FIG. 13B.

FIG. 14A illustrates the apparatus of the invention applied on the smallintestines of a colostomy patient having a stoma opening in the abdomen.

FIG. 14B illustrates the apparatus of the invention applied on the smallintestines of a colostomy patient having the small intestines ending atthe patient's anus.

FIG. 15 is a schematic sectional view of a mechanically operablenon-inflatable constriction device for use in accordance with theinvention.

FIGS. 16 and 17 are cross-sectional views taken along the lines XVI-XVIand XVII-XVII, respectively, of FIG. 15.

FIG. 18 schematically shows an alternative design of the embodiment ofFIG. 15;

FIG. 19 schematically illustrates a motor arrangement for the designaccording to FIG. 18;

FIGS. 20 and 21 are schematic sectional views of two alternative designsof non-inflatable constriction devices of the invention.

FIGS. 22 and 23 illustrate a fully open and a reduced constrictionopening, respectively, of the embodiment of FIG. 21;

FIG. 24 is a schematic view of a further alternative design of anon-inflatable constriction device of the invention.

FIGS. 25 and 26 illustrate a fully open and a reduced constrictionopening, respectively, of the embodiment of FIG. 24;

FIG. 27 is a schematic view of another alternative design of anon-inflatable constriction device of the invention.

FIGS. 28 and 29 are schematic sectional views, respectively, of yetanother alternative design of a non-inflatable constriction device ofthe invention.

FIG. 30A is a schematic view of a hydraulically operable inflatableconstriction device for use in accordance with the invention.

FIG. 30B is the same embodiment shown in FIG. 30A with the constrictiondevice inflated.

FIGS. 31A, 31B, 31C and 31D are block diagrams illustrating fourdifferent principles' for hydraulic operation of the constriction deviceshown in FIG. 30A.

FIG. 32 is a cross-sectional view of a reservoir having a variablevolume controlled by a remote control motor.

FIGS. 33A and 33B are perspective views of a reverse servo in accordancewith a particular embodiment of the hydraulic operation principle shownin FIG. 31C.

FIG. 34 is a schematic view of another hydraulically operableconstriction device for use in accordance with the invention.

FIG. 35A illustrates the constriction device of FIG. 34 in a constrictedstate.

FIG. 35B illustrates the constriction device of FIG. 34 in a releasedstate.

FIGS. 36A-36E schematically illustrate different operation stages of anembodiment of the invention, in which a constriction device and astimulation device co-operate to move the fluid and/or other bodilymatter in the lumen of a patient's organ.

FIG. 37 is a schematic block diagram illustrating a general embodimentof the apparatus of the invention, in which energy is transferred toenergy consuming components of the apparatus implanted in the patient.

FIGS. 38 to 49 are schematic block diagrams illustrating twelveembodiments, respectively, based on the general embodiment shown in FIG.37, wherein wireless energy is transmitted from outside a patient's bodyto energy consuming components of the apparatus implanted in thepatient.

FIG. 50 illustrates an energy-transforming device in the form of anelectrical junction element for use in the apparatus of the presentinvention.

FIG. 51 is a block diagram illustrating control components of anembodiment of the invention.

FIG. 52 is a schematic view of exemplary circuitry of an embodiment ofthe invention, in which wireless energy is transformed into a current.

FIGS. 53A-53C schematically illustrate different operation stages ofanother embodiment of the invention of the type shown in FIG. 2, inwhich a constriction device and a stimulation device co-operate to movethe fluid and/or other bodily matter in the lumen of a patient's organ.

FIGS. 54A-54B schematically illustrate different operation stages ofanother embodiment of the invention of the type shown in FIGS. 36A-36E,in which a constriction device and a stimulation device co-operate tomove the fluid and/or other bodily matter in the lumen of a patient'sorgan.

FIG. 55A is a schematic view of another mechanically operablenon-inflatable constriction device for use in accordance with theinvention.

FIG. 55B shows the constriction device of FIG. 55A in a constrictedstate.

FIG. 55C is an end view of the embodiment of FIG. 55B.

FIG. 56 is a schematic block diagram illustrating an arrangement forsupplying an accurate amount of wireless energy used for the operationof the constriction/stimulation unit as described above.

FIG. 57 schematically shows an embodiment of the system, in which theapparatus is operated with wire bound energy.

FIG. 58 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the constriction/stimulation unit as described above.

FIG. 59 is a circuit for the arrangement shown in FIG. 19, according toa possible implementation example.

DETAILED DESCRIPTION OF THE INVENTION

Referring to the drawing figures, like reference numerals designateidentical or corresponding elements throughout the several figures.

FIGS. 1A, 1B and 1C schematically illustrate different states ofoperation of a generally designed apparatus according to the presentinvention, when the apparatus is applied on a wall portion of a bodilyorgan designated BO. The apparatus includes a constriction device and astimulation device, which are designated CSD, and a control devicedesignated CD for controlling the constriction and stimulation devicesCSD. FIG. 1A shows the apparatus in an inactivation state, in which theconstriction device does not constrict the organ BO and the stimulationdevice does not stimulate the organ BO. FIG. 1B shows the apparatus in aconstriction state, in which the control device CD controls theconstriction device to gently constrict the wall portion of the organ BOto a constricted state, in which the blood circulation in theconstricted wall portion is substantially unrestricted and the flow inthe lumen of the wall portion is restricted. FIG. 1C shows the apparatusin a stimulation state, in which the control device CD controls thestimulation device to stimulate different areas of the constricted wallportion, so that almost the entire wall portion of the organ BOcontracts (thickens) and closes the lumen.

FIGS. 1D and 1E show how the stimulation of the constricted wall portioncan be cyclically varied between a first stimulation mode, in which theleft area of the wall portion (see FIG. 1D) is stimulated, while theright area of the wall portion is not stimulated, and a secondstimulation mode, in which the right area of the wall portion (see FIG.1E) is stimulated, while the left area of the wall portion is notstimulated, in order to maintain over time satisfactory bloodcirculation in the constricted wall portion.

It should be noted that the stimulation modes shown in FIGS. 1D and 1Eonly constitute a principle example of how the constricted wall portionof the organ BO may be stimulated. Thus, more than two different areasof the constricted wall portion may be simultaneously stimulated incycles or successively stimulated. Also, groups of different areas ofthe constricted wall portion may be successively stimulated.

FIGURES IF, 1G and 1H illustrate different states of operation of amodification of the general embodiment shown in FIGS. 1A-1E, wherein theconstriction and stimulation devices CSD include several separateconstriction/stimulation elements, here three elements CSDE1, CSDE2 andCSDE3. FIG. 1F shows how the element CSDE1 in a first state of operationis activated to both constrict and stimulate the organ BO, so that thelumen of the organ BO is closed, whereas the other two elements CSDE2and CSDE3 are inactivated. FIG. 1G shows how the element CSDE2 in asecond following state of operation is activated, so that the lumen ofthe organ BO is closed, whereas the other two elements CSDE1 and CSDE3are inactivated. FIG. 1H shows how the element CSDE3 in a followingthird state of operation is activated, so that the lumen of the organ BOis closed, whereas the other two elements CSDE1 and CSDE2 areinactivated. By shifting between the first, second and third states ofoperation, either randomly or in accordance with a predeterminedsequence, different portions of the organ can by temporarily constrictedand stimulated while maintaining the lumen of the organ closed, wherebythe risk of injuring the organ is minimized. It is also possible toactivate the elements CSDE1-CSDE3 successively along the lumen of theorgan to move fluids and/or other bodily matter in the lumen.

FIGS. 1I, 1K and 1L illustrate an alternative mode of operation of themodification of the general embodiment. Thus, FIG. 1I shows how theelement CSDE1 in a first state of operation is activated to bothconstrict and stimulate the organ BO, so that the lumen of the organ BOis closed, whereas the other two elements CSDE2 and CSDE3 are activatedto constrict but not stimulate the organ BO, so that the lumen of theorgan BO is not completely closed where the elements CSDE2 and CSDE3engage the organ BO. FIG. 1K shows how the element CSDE2 in a secondfollowing state of operation is activated to both constrict andstimulate the organ BO, so that the lumen of the organ BO is closed,whereas the other two elements CSDE1 and CSDE3 are activated toconstrict but not stimulate the organ BO, so that the lumen of the organBO is not completely closed where the elements CSDE1 and CSDE3 engagethe organ BO. FIG. 1L shows how the element CSDE3 in a following thirdstate of operation is activated to both constrict and stimulate theorgan BO, so that the lumen of the organ BO is closed, whereas the othertwo elements CSDE1 and CSDE2 are activated to constrict but notstimulate the organ BO, so that the lumen of the organ BO is notcompletely closed where the elements CSDE1 and CSDE2 engage the organBO. By shifting between the first, second and third states of operation,either randomly or in accordance with a predetermined sequence,different portions of the organ can by temporarily stimulated whilemaintaining the lumen of the organ closed, whereby the risk of injuringthe organ is reduced. It is also possible to activate the stimulation ofthe elements CSDE1-CSDE3 successively along the lumen of the organ BO tomove fluids and/or other bodily matter in the lumen.

FIGS. 2-4 show basic components of an embodiment of the apparatusaccording to the invention for controlling a flow of fluid and/or otherbodily matter in a lumen formed by a tissue wall of a patient's organ.The apparatus comprises a tubular housing 1 with open ends, aconstriction device 2 arranged in the housing 1, a stimulation device 3integrated in the constriction device 2, and a control device 4(indicated in FIG. 4) for controlling the constriction and stimulationdevices 2 and 3. The constriction device 2 has two elongate clampingelements 5, 6, which are radially movable in the tubular housing 1towards and away from each other between retracted positions, see FIG.3, and clamping positions, see FIG. 4. The stimulation device 3 includesa multiplicity of electrical elements 7 positioned on the clampingelements 5, 6, so that the electrical elements 7 on one of the clampingelements 5, 6 face the electrical elements 7 on the other clampingelement. Thus, in this embodiment the constriction and stimulationdevices form a constriction/stimulation unit, in which the constrictionand stimulation devices are integrated in a single piece.

The constriction and stimulation devices may also be separate from eachother. In this case, a structure may be provided for holding theelectrical elements 7 in a fixed orientation relative to one another.Alternatively, the electrical elements 7 may include electrodes that areseparately attached to the wall portion of the patient's organ.

FIGS. 5A-5C illustrate in principle the function of the apparatus ofFIG. 2 when the apparatus is applied on a portion 8 of a tubular tissuewall of a patient's organ. Thus, FIG. 5A shows the apparatus in anon-clamping state, in which the clamping elements 5, 6 are in theirretracted positions and the wall portion 8 extends through the open endsof the housing 1 without being constricted by the clamping elements 5,6. FIG. 5B shows the apparatus in a clamping state, in which theclamping elements 5, 6 have been moved from their retracted positions totheir clamping positions, in which the clamping elements 5, 6 gentlyconstrict the wall portion 8 to a constricted state, in which the bloodcirculation in the constricted wall portion 8 is substantiallyunrestricted and the flow in the lumen of the wall portion 8 isrestricted. FIG. 5C shows the apparatus in a stimulation state, in whichthe clamping elements 5, 6 constrict the wall portion 8 and theelectrical elements 7 of the stimulation device 3 electrically stimulatedifferent areas of the wall portion 8, so that the wall portion 8contracts (thickens) and closes the lumen.

When the apparatus is in its stimulation state, it is important tostimulate the different areas of the wall portion 8 in a manner so thatthey essentially maintains their natural physical properties over timeto prevent the areas from being injured. Consequently, the controldevice 4 controls the stimulation device 3 to intermittently stimulateeach area of the wall portion 8 during successive time periods, whereineach time period is short enough to maintain over time satisfactoryblood circulation in the area. Furthermore, the control device 4controls the stimulation of the areas of the wall portion 8, so thateach area that currently is not stimulated restores substantially normalblood circulation before it is stimulated again. To maintain over timethe effect of stimulation, i.e., to keep the lumen closed by maintainingthe wall portion 8 contracted, the control device 4 controls thestimulation device 3 to stimulate one or more of the areas at a time andto shift the stimulation from one area to another over time. The controldevice 4 may control the stimulation device 3 to cyclically propagatethe stimulation of the areas along the tubular wall portion 8, forexample, in accordance with a determined stimulation pattern. To achievethe desired reaction of the tissue wall during the stimulation thereof,the control device may control the stimulation device to, preferablycyclically, vary the intensity of the stimulation of the wall portion 8.

In the embodiment of FIGS. 2-4, the electrical elements 7 form a seriesof fourteen groups of electrical elements 7 extending longitudinallyalong each elongate clamping element 5 and 6, respectively, see FIG. 2.The electrical elements 7 of each group of electrical elements 7 form afirst path of four electrical elements 7 positioned in a row on clampingelement 5 and extending tranverse thereto, and a second path of fourelectrical elements 7 positioned in a row on clamping element 6 andextending tranverse thereto. Thus, the two paths of electrical elements7 extend on mutual sides of the patient's organ. The control device 4controls the stimulation device 3 to successively energize the groups ofelectrical elements 7 in the series of groups in a direction opposite toor, alternatively, in the same direction as that of the flow in thelumen of the patient's organ. Of course, the number of electricalelements 7 of each path of electrical elements 7 can be greater orsmaller than four, and several parallel rows electrical elements 7 canform each path of electrical elements 7.

FIGS. 6A-6C show another embodiment of the invention which includes atubular housing 9 and three elongate clamping elements 10 a, 10 b, 10 c,which are radially movable in the tubular housing 9 towards and awayfrom a central axis thereof between retracted positions, see FIG. 6A,and clamping positions, see FIG. 6B. The three clamping elements 10 a-10c are symmetrically disposed around the central axis of the housing 9.The stimulation device of this embodiment includes electrical elements11 a, 11 b, 11 c that form a series of groups of elements extendinglongitudinally along the elongate clamping elements 10 a-10 c, whereinthe electrical elements 11 a-11 c of each group of electrical elementsform a path of three electrical elements 11 a, 11 b and 11 c extendingcircumferentially around the central axis of the housing 9. The threeelectrical elements 11 a-11 c of each group are positioned on the threeclamping elements 10 a-10 c, respectively. Thus, the path of threeelectrical elements 11 a-11 c extends around the patient's organ. Ofcourse, the number of electrical elements 11 a-11 c of each path ofelectrical elements can be greater than three, and several parallel rowselectrical elements 11 a-11 c can form each path of electrical elements.

FIGS. 7A and 7B show different steps of an electric stimulation modeperformed by the apparatus of FIG. 2 while the clamping elements 5, 6 ofthe apparatus are constricting a portion of a tubular tissue wall of apatient's organ 12 to restrict the flow in the lumen 13 of the organ 12.For the sake of clarity only the clamping elements 5, 6 of theconstriction device 2 are shown in FIGS. 7A, 7B. Thus, FIG. 7Aillustrates how energized electrical elements 7 of groups of electricalelements electrically stimulate a first portion 14 and a second portion15 of the tubular wall to contract and close the lumen 13. FIG. 7Billustrates how energized electrical elements 7 of other groups ofelectrical elements electrically stimulate a third portion 16 of thetubular wall different from the first and second portions to contractand close the lumen 13, while the electrical stimulation of the firstand second portions 14, 15 of the tubular wall has been ceased, so thatsubstantially normal blood circulation in the first and second portionsis restored. In this manner, the electric stimulation of the constrictedtubular wall is shifted over time from one portion of the tubular wallto another to insure recurrent restoration of blood circulation in theconstricted tubular wall.

The control device 4 controls the stimulation device 3 to energize theelectrical elements 7 with electric biphasic pulses, i.e., combinedpositive and negative pulses. The desired stimulation effect is achievedby varying different pulse parameters. Thus, the control device 4controls the stimulation device 3 to vary the pulse amplitude (voltage),the off time period between successive pulses, the pulse duration andthe pulse repetition frequency. The pulse current should be between 1 to30 mA. For neural stimulation, a pulse current of about 5 mA and a pulseduration of about 300 μs are suitable, whereas a pulse current of about20 mA and a pulse duration of about 30 μs are suitable for muscularstimulation. The pulse repetition frequency suitably is about 10 Hz. Forexample, as illustrated in the Pulse/time diagram P/t of FIGURE BA, apulse combination including a negative pulse PS of short duration andhigh amplitude (voltage), and a positive pulse PL of long duration andlow amplitude following the negative pulse may be cyclically repeated toform a pulse train of such pulse combinations. The energy content of thenegative pulse PS should be substantially equal to the energy content ofthe positive pulse PL.

FIG. 8B is a pulse/time diagram showing a modification of the electricstimulation shown in FIG. 8A. Thus, the pulse combination of FIG. 8A ismixed with a pulse train combination having a first relatively longpulse train PTL of high frequency/low amplitude pulses, appearingsimultaneously with the positive pulse PL of the pulse combination ofFIG. 8A, and a second relatively short pulse train PTS of highfrequency/low amplitude appearing simultaneously with the negative pulsePS of the pulse combination shown in FIG. 8A. As a result, the highfrequency/low amplitudes pulse trains PTL and PTS are superimposed onthe positive and negative pulses PL and PS of FIG. 8A, as illustrated inFIG. 8B. The pulse configuration of FIG. 8B, and variations thereof, isbeneficial to use in connection with the stimulation of particular humanorgans, in order to achieve the desired stimulation effect.

Preferably, the electric pulses form pulse trains, as illustrated in thePulse/time diagrams Pit of FIGS. 9A, 9B, 9C and 9D. The Pulse/timediagram Pit of FIG. 9A represents an individual area of the wall portionof the patient's tubular organ which is stimulated with a pulse train18A. The pulse train 18A includes three initial negative pulses, each ofwhich is of short duration and high amplitude (voltage), and onepositive pulse of long duration and low amplitude following the negativepulses. After a delay to enable the area of the organ to restoresubstantially normal blood circulation, the pulse train 18A is repeated.

The Pulse/time diagram P/t of FIG. 9B represents another individual areaof the wall portion, which is stimulated with a pulse train 18B havingthe same configuration as the pulse train 18A. The pulse trains 18A and18B are shifted relative to each other, so that they partially overlapone another to ensure that the constricted wall portion always isstimulated to contract as desired.

The pulse/time diagrams P/t of FIGS. 10A and 10B represent two differentareas of the wall portion, which are stimulated with cyclically repeatedpulse trains 18C and 18D, respectively, having the same configuration.Each pulse train 18C, 18D includes two initial negative pulses, each ofwhich is of short duration and high amplitude (voltage), and onepositive pulse of long duration and low amplitude following the twonegative pulses. In this case, the pulse trains 18C and 18D are shiftedrelative to each other, so that they do not overlap each other. Thus,the off time period between adjacent pulse trains 18C is longer than theduration of pulse train 18D and the off time period between adjacentpulse trains 18D is longer than the duration of pulse train 18C.

The pulse trains 18A, 18B, 18C and 18D can be configured in manydifferent ways. Thus, the control device 4 can control the stimulationdevice 2 to vary the length of each pulse train, the repetitionfrequency of the pulse trains, the number of pulses of each pulse train,and/or the off time periods between the pulse trains. Typically, thecontrol device 4 controls each off time period between the pulse trainsto last long enough to restore substantially normal blood circulation inthe area that just has been stimulated before that area again isstimulated with electric pulses.

FIGS. 11A and 11B show another embodiment of the invention that controlsblood flow in a blood vessel 19, comprising a constriction device withtwo clamping elements 20 a and 20 b, a stimulation device in the form oftwo thermal stimulation elements 21 a and 21 b integrated in theclamping elements 20 a, 20 b, respectively, and a control device 4 forcontrolling the clamping elements 20 a, 20 b and stimulation elements 21a, 21 b. The clamping elements 20 a and 20 b are movable towards andaway from each other in the same manner as described above in connectionwith the embodiment according to FIGS. 5A-5C. The thermal stimulationelements 21 a and 21 b, which may include Pertier elements, arepositioned on the clamping elements 20 a, 20 b, so that the thermalelements 21 a are facing the thermal elements 21 b. FIG. 11A shows howthe clamping elements 20 a, 20 b constrict the blood vessel 19, so thatthe blood flow is restricted. FIG. 11B shows how the control device 4controls the thermal stimulation elements 21 a, 21 b to cool the wall ofthe blood vessel 19, so that the wall contracts and closes the bloodvessel 19. To release the blood vessel 19, the control device 4 controlsthe thermal stimulation elements 21 a, 21 b to heat the wall of theblood vessel 19, so that the wall expands.

FIGS. 12A and 12B show hydraulic operation means suited for operatingthe constriction device of the embodiments described above.Specifically, FIGS. 12A and 12B show the apparatus of FIG. 2 providedwith such means for hydraulic operation of the constriction device 2.(The stimulation device is not shown.) Thus, the housing 1 forms twohydraulic chambers 22 a and 22 b, in which the two clamping elements 5,6 are slidable back and forth relative to the tubular tissue wallportion 8 of a patient's organ. The hydraulic operation means include anexpandable reservoir 23, such as an elastic balloon, containinghydraulic fluid, conduits 24 a and 24 b between the reservoir 23 and thehydraulic chambers 22 a, 22 b, and a two-way pump 25 for pumping thehydraulic fluid in the conduits 24 a, 24 b. The control device 4controls the pump 25 to pump hydraulic fluid from the reservoir 23 tothe chambers 22 a, 22 b to move the clamping elements 5, 6 against thewall portion 8, whereby the tubular wall portion 8 is constricted, seeFIG. 12B, and to pump hydraulic fluid from the chambers 22 a, 22 b tothe reservoir 23 to move the clamping elements 5, 6 away from the wallportion 8, whereby the tubular wall 8 is released, see FIG. 12A.

Alternatively, the embodiment of FIGS. 12A and 12B may be manuallyoperated by applying suitable manually operable hydraulic means fordistributing the hydraulic fluid between the expandable reservoir 23 andthe hydraulic chambers 22 a, 22 b. In this case the pump 25 is omitted.

FIGS. 13A and 138 schematically show a mechanically operable embodimentof the invention, comprising an open ended tubular housing 26 applied onthe tubular tissue wall portion 8 of a patient's organ, a constrictiondevice 27 arranged in the housing 26 and a control device 4 forcontrolling the constriction device 27. A stimulation device (not shown)as described above is also provided in the housing 26. The constrictiondevice 27 includes a clamping element 28, which is radially movable inthe tubular housing 26 towards and away from the tubular wall portion 8between a retracted position, see FIG. 13A, and a clamping position, seeFIG. 13B, in which the clamping element 28 gently constricts the tubularwall portion 8. Mechanical operation means for mechanically operatingthe clamping element 28 includes an electric motor 29 attached to thehousing 26 and a telescopic device 30, which is driven by the motor 29and operatively connected to the clamping element 28. The control device4 controls the electric motor 29 to expand the telescopic device 30 tomove the clamping element 28 against the wall portion 8, whereby thetubular wall portion 8 is constricted, see FIG. 13B, and controls themotor 29 to retract the telescopic device 30 to move the clampingelement 28 away from the wall portion 8, whereby the wall portion 8 isreleased, see FIG. 13A.

Alternatively, the motor 29 may be omitted and the telescopic device 30be modified for manual operation, as shown in FIG. 13C. Thus, a spring30 a may be provided acting to keep the telescopic device 30 expanded toforce the clamping element 28 against the wall portion 8. The mechanicaloperation means may include a subcutaneously implanted lever mechanism29 a that is operatively connected to the telescopic device 30. Thepatient may push the lever mechanism 29 a through the patient's skin 29b to pull the telescopic device 30 against the action of the spring 30 ato the retracted position of the telescopic device 30, as indicated inphantom lines. When the patient releases the lever mechanism 29 a, thespring 30 a expands the telescopic device 30, whereby clamping element28 is forced against the wall portion 8.

The mechanical operation means as described above in connection withFIGS. 13A, 136 and 13C may also be implemented in the embodimentsaccording to FIGS. 1-11.

FIG. 14A illustrates the embodiment of FIG. 2 applied on the smallintestines 31 of a colostomy patient having a stoma in the abdomen. Theclamping elements 5, 6 of the constriction device 2 constrict the smallintestines 31 and the stimulation device 3 is energized to close theintestinal passageway. (For the sake of clarity, the housing is notshown and the clamping elements 5, 6 are exaggerated.) In thisembodiment, a control device includes an external control unit in theform of a hand-held wireless remote control 32, and an implantedinternal control unit 33, which may include a microprocessor, forcontrolling the constriction and stimulation devices. The remote control32 is operable by the patient to control the internal control unit 33 toswitch on and off the constriction device and/or the stimulation device.Alternatively, however, the remote control 32 may be replaced by asubcutaneously implanted push button that is manually switched by thepatient between “on” and “off”. Such a manually operable push button mayalso be provided in combination with the remote control 32 as anemergency button to allow the patient to stop the operation of theapparatus in case of emergency or malfunction.

The internal control unit 33 controls an implanted operation device 34to move the clamping elements 5, 6. An implanted source of energy 35,such as a rechargeable battery, powers the operation device 34. Theinternal control unit 33, which may be implanted subcutaneously or inthe abdomen, also works as en energy receiver, i.e., for transformingwireless energy into electric energy and charging the implanted sourceof energy 35 (rechargeable battery) with the electric energy.

An implanted sensor 36 senses a physical parameter of the patient, suchas the pressure in the intestines, or a parameter that relates to thepressure in the intestines, wherein the internal control unit 33controls the constriction device 2 and/or the stimulation device 3 inresponse to signals from the sensor 36. In this embodiment the sensor 36is a pressure sensor, wherein the internal control unit 33 controls theconstriction device and/or stimulation device to change the constrictionof the patient's intestines 31 in response to the pressure sensor 36sensing a predetermined value of measured pressure. For example, thecontrol unit 33 may control the constriction device and/or stimulationdevice to increase the constriction of the patient's intestines 31 inresponse to the pressure sensor sensing an increased pressure.Alternatively or in combination, the remote control 32 controls theconstriction device and/or stimulation device in response to signalsfrom the sensor 36, in the same manner as the internal control unit 33.

The remote control 32 may be equipped with means for producing anindication, such as a sound signal or displayed information, in responseto signals from the sensor 36. When the patient's attention is taken bysuch an indication indicating an increased pressure exceeding athreshold value, he or she may use the remote control to control theconstriction device and stimulation device to pump intestinal contentsthrough the patient's stoma.

FIG. 14B shows an embodiment which is similar to the embodiment of FIG.14A except that the constriction device is applied on the smallintestines of a colostomy patient having the small intestines surgicallyconnected to the patient's anus.

Of course, the constriction device 2 shown in FIGS. 14A and 14B may bereplaced by any one of the constriction devices described in the variousembodiments of the present invention, where applicable.

FIGS. 15-17 show a mechanically operable constriction device having anelongated constriction member in the form of a circular resilient core37 with two overlapping end portions 38, 39. The core 37 defines asubstantially circular restriction opening and is enclosed in an elasticsoft hose 40 except at a releasable and lockable joint 41 of the core37, which when released enables application of the core 37 with its hose40 around a portion of a tubular tissue wall of a patient's organ. Thematerials of all of these elements are bio-compatible so that thepatient’ body will not reject them. An operation device 42 formechanically operating the longitudinal extension of the core 37 tochange the size of the restriction opening comprises a drive wheel 43 infrictional engagement with the overlapping end portions 38, 39 of thecore 37. The drive wheel 43 is journalled on a holder 44 placed in thehose 40 and provided with two counter pressure rollers 45, 46 pressingthe respective end portions 38, 39 of the core 37 against the drivewheel 43 to increase the frictional engagement there between. Anelectric motor 47 of the operation device is connected to the drivewheel 43 via a long flexible drive shaft 48, and is moulded togetherwith a remote controlled power supply unit 49 in a body 50 of siliconerubber. The length of the flexible drive shaft 48 is selected so thatthe body 50 can be placed in a desired position in the patient's body,suitably in the abdomen.

The power supply unit 49 can be controlled to power the electric motor47 to turn the drive wheel 43 in one direction to reduce the diameter ofthe core 37, so that the wall portion is constricted, or to turn thedrive wheel 43 in the opposite direction to increase the diameter of thecore 37, so that the wall portion is released.

In accordance with a first alternative, a rack gear may be formed on oneof the end portions 38, 39 of the core 37 and the drive wheel 43 may bereplaced by a drive gear wheel connected to the other end portion of thecore 37 and in mesh with the rack gear.

In accordance with a second alternative, the operation device 42 may bedesigned as a worm-driven hose clamp, i. e., one of the end portions 38,39 of the core 37 may be provided with threads and the other end portionof the core 37 may be provided with a worm, the threads of whichinteracts with the threads of said one end portion of the core 37. Thethreads of such a worm may also interact with threads provided on bothend portions 38, 39 of the core 37. In this alternative, the electricmotor 47 turns the worm in one direction to reduce the diameter of thecore 37, so that the wall portion is constricted, or turn the worm inthe opposite direction to increase the diameter of the core 37, so thatthe wall portion is released in one direction to reduce the diameter ofthe core 37, so that the wall portion is constricted, or turns theclamping screw in the opposite direction to increase the diameter of thecore 37, so that the wall portion is released.

FIG. 18 shows a constriction device which is identical to the embodimentof FIGS. 15-17, except that the motor 47 is encapsulated in the hose 40so that it is fixed to the core 37 and has a short drive shaft 51, andthat the motor 47 is positioned relative to the core 37, such that thedrive shaft 51 extends substantially tangentially to the circular core37. There is an angular gearing 52 connecting the drive shaft 51 to thedrive wheel 43.

FIG. 19 shows a suitable alternative arrangement for the motor 47 in theembodiment of FIG. 18, comprising a first clamping member 53 secured toone end portion of the core 37 and a second clamping member 54 securedto the other end portion 39 of the core 37. The motor 47 is secured tothe first clamping member 53 and is operatively connected to a worm gear55 via a gear transmission 56. The worm gear 55 is journalled at itsopposite ends on holders 57 and 58, which are rigidly secured to theclamping member 53 and the motor 47, respectively. The second clampingmember 54 has a pinion in mesh with the worm gear 55. When the motor 47is powered, the worm gear 55 rotates, and will thereby pull the endportion 39 of the core 37 in one or the opposite longitudinal direction,so that the diameter of the substantially circular core 37 is eitherincreased or decreased. The motor 47, worm gear 55, gear transmission 56and second clamping member 54 constitute a servo system of the type thattransfers a weak force acting on a moving element having a long strokeinto a strong force acting on another moving element having a shortstroke.

FIG. 20 shows a constriction device including a plurality of arcuatelamellae 59 arranged like the conventional adjustable aperture mechanismof a camera. A motor 60 operates the lamellae 59 to change the size of arestriction opening defined by the lamellae 59.

FIGS. 21-23 show a constriction device including two semi-circularelements 61 and 62, which are hinged together such that thesemi-circular elements 61, 62 are swingable relative to each otherbetween a fully open state in which they substantially form a circle, asillustrated in FIG. 22, and an angular state, in which the size of therestriction opening defined by the semi-circular elements 61, 62 isreduced, as illustrated in FIG. 23. A motor 63 operates thesemi-circular elements 61, 62 to swing them relative to each other.

FIGS. 24-26 show a constriction device including an elastic belt 64forming a circle and having a substantially oval cross-section. A motor67 operates the belt 64 to turn around the longitudinal extensionthereof between a fully open state, in which the inner broader side ofthe belt 64 forms a substantially cylindrical surface, as illustrated inFIG. 25, and a reduced open state, in which the inner broader side ofthe belt 64 forms a substantially conical surface, as illustrated inFIG. 26.

FIG. 27 shows a constriction device 68 having two rigid articulatedclamping elements 69 positioned on opposite sides of a portion of atubular tissue wall 70 of a patient's organ. An operation device 71turns the clamping elements 69 toward each other to clamp the wallportion 70 between the clamping elements 69 to thereby contract the wallportion, and turns the clamping elements 69 away from each other torelease the wall portion from the clamping elements 69.

FIGS. 28 and 29 show an embodiment of the apparatus of the inventioncomprising a constriction device 300 having three bending members 301,302 and 303 displaced relative to one another in a row along a portionof a tubular tissue wall 304 of a patient's organ and positionedalternately on opposite sides of the tubular wall 304. (Alternatively,each member 301, 302 and 303 may take the shape of an hour-glass.) Anoperation device (not shown) moves the two outer members 301, 303laterally against the tubular wall 304 in one direction and theintermediate member 302 against the tubular wall 304 in the oppositedirection to bend the tubular wall 304, to thereby constrict the tubularwall portion 304, as illustrated in FIG. 29. To release the wall portion304 the operation device moves the members 301-303 away from the tubularwall portion 304 to the position shown in FIG. 28.

FIGS. 30A and 30B show a hydraulically operable elongated constrictiondevice in the form of a band 72 having an expandable/contractible cavity73, which is in fluid communication with an adjustable reservoir 74containing hydraulic fluid. FIG. 30A illustrates when the band is in anon-constriction state, whereas FIG. 30B illustrates when the band is ina constriction state, in which the cavity 73 is expanded by hydraulicfluid supplied by the reservoir 74.

FIGS. 31A, 31B, 31C and 31D are block diagrams of four differentlyoperated hydraulic constriction devices. FIG. 31A shows the band 72 ofFIG. 30A, the cavity 73 of which is in fluid communication with areservoir 75. FIG. 31B shows the embodiment of FIG. 30A, in which thecavity 73 of the band 72 is in fluid communication with the reservoir 74via an operation device in the form of a two-way pump 76. FIG. 31C showsan operation device in the form of a reverse servo system with a firstclosed system controlling a second system. The reverse servo systemcomprises an adjustable fluid supply reservoir 77 and an adjustableservo reservoir 78. The servo reservoir 78 controls a larger adjustablereservoir 79 which in connection with the band 72 applied around aportion of tubular tissue wall of a patient's organ varies the volume ofthe cavity 73 of the band 72, which in turn varies the constriction ofthe wall portion. FIG. 31D shows an embodiment identical to theembodiment of FIG. 31C, except that the larger reservoir 79 is omitted.Instead, the servo reservoir 78 is in fluid communication with thecavity of the band 72.

In all of the above embodiments according to FIGS. 12A through 30B,stimulation devices may be provided to form constriction/stimulationunits, in which the stimulation devices include a multiplicity ofelectrical elements 7 (indicated in FIGS. 12A-15, 18, 20-23, 26-31B)positioned on the constriction devices.

FIG. 32 is a cross-sectional view of a fluid supply device including abellows reservoir 80 defining a chamber 81, the size of which isvariable by an operation device comprising a remote controlled electricmotor 82. The reservoir 80 and the motor 82 are placed in a housing 83.Moving a large wall 84 varies the chamber 81. The wall 84 is secured toa nut 85, which is threaded on a rotatable spindle 86. The spindle 86 isrotated by the motor 82. A battery 89 placed in the housing 83 powersthe motor 82. A signal receiver 90 for controlling the motor 82 is alsoplaced in the housing 83. Alternatively, the battery 89 and the signalreceiver 90 may be mounted in a separate place. The motor 82 may also bepowered with energy transferred from transmitted signals.

Where applicable, the fluid supply device of FIG. 32 may be used forsupplying hydraulic fluid for the operation of the constriction devicesdescribed in this specification. For example, the fluid supply device ofFIG. 32 may be substituted for the reservoir 74 in the embodimentaccording to FIG. 30A.

FIGS. 33A and 33B show a reverse servo including a rectangular housing91 and an intermediate wall 92, which is movable in the housing 91. Arelatively large, substantially cylindrical bellows reservoir 93 isarranged in the housing 91 and is joined to the movable intermediatewall 92. Another cylindrical bellows reservoir 94, which issubstantially smaller than reservoir 93, is arranged in the housing 91at the other side of the intermediate wall 92 and is also joined to thewall 92. The small bellows reservoir 94 has a fluid supply pipe 95 andthe large bellows reservoir 93 has a fluid supply pipe 96.

Referring to FIG. 33A, when a small amount of hydraulic fluid isconducted through the supply pipe 95 into the small bellows reservoir94, the small bellows reservoir 94 expands and pushes the movableintermediate wall 92 towards the large bellows reservoir 93. As aresult, the large bellows reservoir 93 is contracted by the intermediatewall 92, whereby a large amount of hydraulic fluid is forced out of thelarge bellows reservoir 93 through the supply pipe 96, as shown in FIG.33B.

For example, the reverse servo of FIGS. 33A and 33B may be used in theembodiment of FIG. 31C, wherein the small bellows reservoir 94corresponds to the small servo reservoir 78 and the large bellowsreservoir 93 corresponds to the large reservoir 79. Also, the reverseservo of FIGS. 33A and 33B may be used in the embodiment of FIGS. 30Aand 30B, wherein the small bellows reservoir 94 is connected to theadjustable reservoir 74, and the large bellows reservoir 93 is connectedto the cavity 73 of the band 72.

FIG. 34 schematically shows a hydraulically operable constriction device97 of the apparatus of the invention, which is similar to the embodimentshown in FIG. 30A, except that the hydraulic system is designeddifferently. Thus, the constriction device 97 includes a relativelysmall inflatable cavity 98, which is in fluid communication with areservoir 99 containing hydraulic fluid, and a relatively large cavity100, which is displaceable by small cavity 98. Small cavity 98 isadapted to displace large cavity 100 to constrict the patient's tubularwall portion when small cavity 98 is inflated and to displace largecavity 100 to release the wall portion when small cavity 98 is deflated.Thus, a relatively small addition of hydraulic fluid from reservoir 99to small cavity 98 causes a relatively large increase in theconstriction of the wall portion.

Large cavity 100 is defined by a contraction element in the form of abig balloon 101, which may be connected to an injection port (not shown)for calibration of the volume of large cavity 100. Adding fluid to orwithdrawing fluid from the injection port with the aid of a syringecalibrates the volume of balloon 101. Small cavity 98 is defined by asmall bellows 102 attached to an annular frame 103 of constrictiondevice 97 and at the opposite end is attached to balloon 101.

FIGS. 35A and 35B schematically illustrate the operation of constrictiondevice 97, when annular frame 103 is applied around the tubular wallportion of the patient's organ. Referring to FIG. 35A, when small cavity98 is deflated bellows 102 pulls balloon 101 inwardly into annular frame103, so that constriction device 97 constricts the wall portion.Referring to FIG. 35B, when small cavity 98 is inflated bellows 102pulls balloon 101 out of annular frame 103, so that constriction device97 releases the wall portion.

As mentioned above, the constriction device and stimulation device canco-operate to actively move the fluid and/or other bodily matter in thelumen of a patient's organ. This can be achieved using theconstriction/stimulation unit shown in FIG. 2. Thus, in accordance witha first cooperation option, the clamping elements 5, 6 of theconstriction device constricts the wall portion 8 without completelyclosing the lumen, whereby the flow in the lumen is restricted, and thecontrol device 4 controls the electrical elements 7 to progressivelystimulate the constricted wall portion in the downstream or upstreamdirection of the lumen to cause progressive contraction of the wallportion 8 to move the fluid and/or other bodily matter in the lumen.

In accordance with a second cooperation option, the constriction deviceconstricts the wall portion so that the flow in the lumen is restricted,and the control device 4 controls a few electrical elements 7 at one endof the elongate clamping elements 5, 6 to stimulate the constricted wallportion 8 to close the lumen either at an upstream end or a downstreamend of the wall portion 8. With the lumen closed in this manner, thecontrol device 4 controls the constriction device to increase theconstriction of the wall portion, whereby the fluid and/or other bodilymatter in the lumen is moved downstream or upstream of the wall portion8.

In another embodiment of the invention for performing the secondcooperation option, the constriction device constricts the wall portionso that the flow in the lumen is restricted, and the control device 4controls the stimulation device to stimulate the constricted wallportion while the constriction device varies the constriction of thedifferent areas of the wall portion, such that the wall portion isprogressively constricted in the downstream or upstream direction of thelumen. FIGS. 36A-36E show different operation stages of such analternative embodiment, which comprises a constriction device 104including two elongate constriction elements 105, 106 having convexsurfaces 107, 108 that abut a length of the wall portion 8 on mutualsides thereof, and a multiplicity of electrical elements 7 (such aselectrodes) that are positioned on the convex surfaces 107, 108. Thecontrol device 4 controls the electrical elements 7 during operation ofthe constriction device 104 and controls the elongate constrictionelements 105, 106 to move relative to the tubular wall portion 8 so thatthe constriction elements 105, 106 progressively constrict the wallportion 8, as appears from FIGS. 36A to 36D.

Thus, in an initial position of the constriction elements 105, 106 shownin FIG. 36A, the wall portion is not constricted by the constrictionelements 105, 106 and the electrical elements 7 are not energized.Starting from this initial position, the control device 4 controls theconstriction elements 105, 106 to swing the left ends of theconstriction elements 105, 106 toward the wall portion (indicated byarrows) to constrict the tubular wall portion 8, see FIG. 36B, whileenergizing the electrical elements 7, so that the electrical elements 7that contact the wall portion 8 contract the latter. FIG. 36 C shows howthe lumen of the tubular wall portion 8 is completely closed by thethickened wall portion 8. Then, as shown in FIG. 36C, the control device4 controls the constriction elements 105, 106 to move so that theirright ends are moving towards each other (indicated by arrows), whilethe convex surfaces 107, 108 of the constriction elements 105, 106 arerolling on each other with the contracted wall portion 8 between them,see FIG. 36D. As a result, the bodily matter in the lumen of the organis forced to the right (indicated by a white arrow). When theconstriction elements 105, 106 have rolled on each other to the positionshown in FIG. 36E, the control device 4 controls the right ends of theconstriction elements 105, 106 to move away from each other (indicatedby arrows in FIG. 36E) to the initial position shown in FIG. 36k Theoperation stages described according to FIGS. 36A to 36E can becyclically repeated a number of times until the desired amount of bodilymatter has been moved in the lumen of the organ in a peristaltic manner.

Alternatively, only one of the constriction elements 105, 106 can beprovided with a convex surface, whereas the other constriction elementhas a plane surface that abuts the wall portion. It is also possible touse a single constriction element with a convex surface that presses thetubular portion 8 of the organ against a bone of the patient.

In the embodiment according to FIGS. 36A to 36E, the control device 4may control the electrical elements 7 to progressively stimulate theconstricted wall portion 8 to cause progressive contraction thereof inharmony with the movement of the elongate constriction elements 105,106, as the convex surfaces 107, 108 of the constriction elements 105,106 are rolling on each other.

FIG. 37 schematically shows a general embodiment of the apparatus of theinvention, in which energy is transferred to energy consuming componentsof the apparatus implanted in the patient. The apparatus of FIG. 37comprises an implanted constriction/stimulation unit 110, which isoperable to gently constrict a portion of a tubular tissue wall of apatient's organ and to stimulate different areas of the constrictedportion to cause contraction of the wall portion. The constrictiondevice of the constriction/stimulation unit 110 is capable of performinga reversible function, i.e., to constrict and release the wall portion,so that the constriction/stimulation unit 110 works as an artificialsphincter.

A source of energy 111 is adapted to supply energy consuming componentsof the constriction/stimulation unit 110 with energy via a power supplyline 112. A wireless remote control or a subcutaneously implanted switchoperable by the patient to switch on or off the supply of energy fromthe source of energy may be provided. The source of energy may be animplantable permanent or rechargeable battery, or be included in anexternal energy-transmission device, which may be operable directly bythe patient or be controlled by a remote control operable by the patientto transmit wireless energy to the energy consuming components of theconstriction/stimulation unit. Alternatively, the source of energy maycomprise a combination of an implantable rechargeable battery, anexternal energy-transmission device and an implantableenergy-transforming device for transforming wireless energy transmittedby the external energy-transmission device into electric energy for thecharge of the implantable rechargeable battery.

FIG. 38 shows a special embodiment of the general embodiment of FIG. 37having some parts implanted in a patient and other parts located outsidethe patient's body. Thus, in FIG. 38 all parts placed to the right ofthe patient's skin 109 are implanted and all parts placed to the left ofthe skin 109 are located outside the patient's body. An implantedenergy-transforming device 111A of the apparatus is adapted to supplyenergy consuming components of the constriction/stimulation unit 110with energy via the power supply line 112. An externalenergy-transmission device 113 of the apparatus includes a wirelessremote control transmitting a wireless signal, which is received by asignal receiver incorporated in the implanted energy-transforming device111A. The implanted energy-transforming device 111A transforms energyfrom the signal into electric energy, which is supplied via the powersupply line 112 to the constriction/stimulation unit 110.

The apparatus of FIG. 38 may also include an implanted rechargeablebattery for energizing energy consuming implanted components of theapparatus. In this case, the implanted energy-transforming device 111Aalso charges the battery with electric energy, as theenergy-transforming device transforms energy from the signal into theelectric energy.

A reversing device in the form of an electric switch 114, such as amicroprocessor, is implanted in the patient for reversing theconstriction device of the constriction/stimulation unit 110. Thewireless remote control of the external energy-transmission device 113transmits a wireless signal that carries energy and the implantedenergy-transforming device 111A transforms the wireless energy into acurrent for operating the switch 114. When the polarity of the currentis shifted by the energy-transforming-device 111A the switch 114reverses the function performed by the constriction device of theconstriction/stimulation unit 110.

FIG. 39 shows an embodiment of the invention including theenergy-transforming device 111A, the constriction/stimulation unit 110and an implanted operation device in the form of a motor 115 foroperating the constriction device of the constriction/stimulation unit110. The motor 115 is powered with energy from the energy-transformingdevice 111A, as the remote control of the external energy-transmissiondevice 113 transmits a wireless signal to the receiver of theenergy-transforming device 111A.

FIG. 40 shows an embodiment of the invention including theenergy-transforming device 111A, the constriction/stimulation unit 110and an implanted assembly 116 including a motor/pump unit 117 and afluid reservoir 118. In this case the constriction device of theconstriction/stimulation unit 110 is hydraulically operated, i.e.,hydraulic fluid is pumped by the motor/pump unit 117 from the reservoir118 to the constriction/stimulation unit 110 to constrict the wallportion, and hydraulic fluid is pumped by the motor/pump unit 117 backfrom the constriction/stimulation unit 110 to the reservoir 118 torelease the wall portion. The implanted energy-transforming device 111Atransforms wireless energy into a current, for powering the motor/pumpunit 117.

FIG. 41 shows an embodiment of the invention comprising the externalenergy-transmission device 113 that controls the control unit 122 toreverse the motor 115 when needed, the constriction/stimulation unit110, the constriction device of which is hydraulically operated, and theimplanted energy-transforming device 111A, and further comprising animplanted hydraulic fluid reservoir 119, an implanted motor/pump unit120, an implanted reversing device in the form of a hydraulic valveshifting device 121 and a separate external wireless remote control111B. The motor of the motor/pump unit 120 is an electric motor. Inresponse to a control signal from the wireless remote control of theexternal energy-transmission device 113, the implantedenergy-transforming device 111A powers the motor/pump unit 120 withenergy from the energy carried by the control signal, whereby themotor/pump unit 120 distributes hydraulic fluid between the reservoir119 and the constriction device of the constriction/stimulation unit110. The remote control 1118 controls the shifting device 121 to shiftthe hydraulic fluid flow direction between one direction in which thefluid is pumped by the motor/pump unit 120 from the reservoir 119 to theconstriction device of the constriction/stimulation unit 110 toconstrict the wall portion, and another opposite direction in which thefluid is pumped by the motor/pump unit 120 back from the constrictiondevice of the constriction/stimulation unit 110 to the reservoir 119 torelease the wall portion.

FIG. 42 shows an embodiment of the invention including theenergy-transforming device 111A and the constriction/stimulation unit110. A control unit 122, an accumulator 123 and a capacitor 124 are alsoimplanted in the patient. A separate external wireless remote control111B controls the control unit 122. The control unit 122 controls theenergy-transforming device 111A to store electric energy in theaccumulator 123, which supplies energy to the constriction/stimulationunit 110. In response to a control signal from the wireless remotecontrol 111B, the control unit 122 either releases electric energy fromthe accumulator 123 and transfers the released energy via power lines,or directly transfers electric energy from the energy-transformingdevice 111A via the capacitor 124, which stabilises the electriccurrent, for the operation of the constriction/stimulation unit 110.

In accordance with one alternative, the capacitor 124 in the embodimentof FIG. 42 may be omitted. In accordance with another alternative, theaccumulator 123 in this embodiment may be omitted.

FIG. 43 shows an embodiment of the invention including theenergy-transforming device 111A, the constriction/stimulation unit 110.A battery 125 for supplying energy for the operation of theconstriction/stimulation unit 110 and an electric switch 126 forswitching the operation of the constriction/stimulation unit 110 arealso implanted in the patient. The switch 126 is operated by the energysupplied by the energy-transforming device 111A to switch from an offmode, in which the battery 125 is not in use, to an on mode, in whichthe battery 125 supplies energy for the operation of theconstriction/stimulation unit 110.

FIG. 44 shows an embodiment of the invention identical to that of FIG.43, except that a control unit 122 also is implanted in the patient. Aseparate external wireless remote control 1118 controls the control unit122. In this case, the switch 126 is operated by the energy supplied bythe energy transforming device 111A to switch from an off mode, in whichthe wireless remote control 111B is prevented from controlling thecontrol unit 122 and the battery 125 is not in use, to a standby mode,in which the remote control 111B is permitted to control the controlunit 122 to release electric energy from the battery 125 for theoperation of the constriction/stimulation unit 110.

FIG. 45 shows an embodiment of the invention identical to that of FIG.44, except that the accumulator 123 is substituted for the battery 125and the implanted components are interconnected differently. In thiscase, the accumulator 123 stores energy from the energy-transformingdevice 111A. In response to a control signal from the wireless remotecontrol 111B, the implanted control unit 122 controls the switch 126 toswitch from an off mode, in which the accumulator 123 is not in use, toan on mode, in which the accumulator 123 supplies energy for theoperation of the constriction/stimulation unit 110.

FIG. 46 shows an embodiment of the invention identical to that of FIG.45, except that the battery 125 also is implanted in the patient, andthe implanted components are interconnected differently. In response toa control signal from the wireless remote control 111B, the implantedcontrol unit 122 controls the accumulator 123, which may be a capacitor,to deliver energy for operating the switch 126 to switch from an offmode, in which the battery 125 is not in use, to an on mode, in whichthe battery 125 supplies electric energy for the operation of theconstriction/stimulation unit 110.

Alternatively, the switch 126 may be operated by energy supplied by theaccumulator 123 to switch from an off mode, in which the wireless remotecontrol 111B is prevented from controlling the battery 125 to supplyelectric energy and the battery 125 is not in use, to a standby mode, inwhich the wireless remote control 111B is permitted to control thebattery 125 to supply electric energy for the operation of theconstriction/stimulation unit 110.

FIG. 47 shows an embodiment of the invention identical to that of FIG.43, except that a motor 115, a mechanical reversing device in the formof a gearbox 127 and a control unit 122 for controlling the gearbox 127also are implanted in the patient. A separate external wireless remotecontrol 111B controls the implanted control unit 122 to control thegearbox 127 to reverse the function performed by the constriction device(mechanically operated) of the constriction/stimulation unit 110.

FIG. 48 shows an embodiment of the invention identical to that of FIG.46, except that the implanted components are interconnected differently.Thus, in this case, the battery 125 powers the control unit 122 when theaccumulator 123, suitably a capacitor, activates the switch 126 toswitch to an on mode. When the switch 126 is in its on mode the controlunit 122 is permitted to control the battery 125 to supply, or notsupply, energy for the operation of the constriction/stimulation unit110.

FIG. 49 shows an embodiment of the invention identical to that of FIG.39, except that a gearbox 127 that connects the motor 115 to theconstriction/stimulation unit 110, and a control unit 122 that controlsthe energy-transforming device 111A to power the motor 115 also areimplanted in the patient. There is a separate external wireless remotecontrol 1118 that controls the control unit 122 to reverse the motor 115when needed.

Optionally, the accumulator 123 shown in FIG. 42 may be provided in theembodiment of FIG. 49, wherein the implanted control unit 122 controlsthe energy-transforming device 111A to store the transformed energy inthe accumulator 123. In response to a control signal from the wirelessremote control 111B, the control unit 122 controls the accumulator 123to supply energy for the operation of the constriction/stimulation unit110.

Those skilled in the art will realise that the above various embodimentsaccording to FIGS. 38-49 could be combined in many different ways. Forexample, the energy operated switch 114 could be incorporated in any ofthe embodiments of FIGS. 39, 42-49, the hydraulic shifting device 121could be incorporated in the embodiment of FIG. 40, and the gearbox 127could be incorporated in the embodiment of FIG. 39. The switch 114 maybe of a type that includes electronic components, for example amicroprocessor, or a FGPA (Field Programmable Gate Array) designed forswitching. Alternatively, however, the energy operated switch 114 may bereplaced by a subcutaneously implanted push button that is manuallyswitched by the patient between “on” and“off”.

Alternatively, a permanent or rechargeable battery may be substitutedfor the energy-transforming devices 111A of the embodiments shown inFIGS. 38-49.

FIG. 50 shows the energy-transforming device in the form of anelectrical junction element 128 for use in any of the above embodimentsaccording to FIGS. 37-49. The element 128 is a flat p-n junction elementcomprising a p-type semiconductor layer 129 and an n-type semiconductorlayer 130 sandwiched together. A light bulb 131 is electricallyconnected to opposite sides of the element 128 to illustrate how thegenerated current is obtained. The output of current from such a p-njunction element 128 is correlated to the temperature. See the formulabelow.

I=I0(exp(qV/kT)−1)

-   -   Where    -   I is the external current flow,    -   I0 is the reverse saturation current,    -   q is the fundamental electronic charge of 1.602×10-19 coulombs,    -   V is the applied voltage,    -   k is the Boltzmann constant, and    -   T is the absolute temperature.

Under large negative applied voltage (reverse bias), the exponentialterm becomes negligible compared to 1.0, and I is approximately −I0. I0is strongly dependent on the temperature of the junction and hence onthe intrinsic-carrier concentration. I0 is larger for materials withsmaller bandgaps than for those with larger bandgaps. The rectifieraction of the diode, that is, its restriction of current flow to onlyone direction, is in this particular embodiment the key to the operationof the p-n junction element 128.

The alternative way to design a p-n junction element is to deposit athin layer of semiconductor onto a supporting material which does notabsorb the kind of energy utilised in the respective embodiments. Foruse with wirelessly transmitted energy in terms of light waves, glasscould be a suitable material. Various materials may be used in thesemiconductor layers, such as, but not limited to, cadmium telluride,copper-indium-diselenide and silicon. It is also possible to use amultilayer structure with several layers of p and n-type materials toimprove efficiency.

The electric energy generated by the p-n junction element 128 could beof the same type as generated by solar cells, in which the negative andpositive fields create a direct current. Alternatively, the negative andpositive semiconductor layers may change polarity following thetransmitted waves, thereby generating the alternating current.

The p-n junction element 128 is designed to make it suited forimplantation. Thus, all the external surfaces of the element 128 incontact with the human body are made of a biocompatible material. Thep-n junction semiconductors are designed to operate optimally at a bodytemperature of 37° C. because the current output, which should be morethan 1 μA, is significantly dependent upon such temperature, as shownabove. Since both the skin and subcutis absorb energy, the relationbetween the sensitivity or working area of the element 128 and theintensity or strength of the wireless energy-transmission is considered.The p-n junction element 128 preferably is designed flat and small.Alternatively, if the element 128 is made in larger sizes it should beflexible, in order to adapt to the patient's body movements. The volumeof the element 128 should be kept less than 2000 cm³.

FIG. 51 shows basic parts of a remote control of the apparatus of theinvention for controlling the constriction/stimulation unit 110. In thiscase, the stimulation device of the constriction/stimulation unitstimulates the wall portion with electric pulses. The remote control isbased on wireless transmission of electromagnetic wave signals, often ofhigh frequencies in the order of 100 kHz-1 gHz, through the skin 132 ofthe patient. In FIG. 51, all parts placed to the left of the skin 132are located outside the patient's body and all parts placed to the rightof the skin 132 are implanted.

An external signal-transmission device 133 is to be positioned close toa signal-receiving device 134 implanted close to the skin 132. As analternative, the signal-receiving device 134 may be placed for exampleinside the abdomen of the patient. The signal-receiving device 134comprises a coil, approximately 1-100 mm, preferably 25 mm in diameter,wound with a very thin wire and tuned with a capacitor to a specifichigh frequency. A small coil is chosen if it is to be implanted underthe skin of the patient and a large coil is chosen if it is to beimplanted in the abdomen of the patient. The signal transmission device133 comprises a coil having about the same size as the coil of thesignal-receiving device 134 but wound with a thick wire that can handlethe larger currents that is necessary. The coil of the signaltransmission device 133 is tuned to the same specific high frequency asthe coil of the signal-receiving device 134.

The signal-transmission device 133 is adapted to send digitalinformation via the power amplifier and signal-receiving device 134 toan implanted control unit 135. To avoid that accidental random highfrequency fields trigger control commands, digital signal codes areused. A conventional keypad placed on the signal transmission device 133is used to order the signal transmission device 133 to send digitalsignals for the control of the constriction/stimulation unit. The signaltransmission device 133 starts a command by generating a high frequencysignal. After a short time, when the signal has energized the implantedparts of the control system, commands are sent to operate theconstriction device of the constriction/stimulation unit 110 inpredefined steps. The commands are sent as digital packets in the formillustrated below.

Start pattern, Command, Count, Checksum, 8 bits 8 bits 8 bits 8 bits

The commands are sent continuously during a rather long time period(e.g., about 30 seconds or more). When a new constriction or releasestep is desired, the Count byte is increased by one to allow theimplanted control unit 135 to decode and understand that another step isdemanded by the signal transmission device 133. If any part of thedigital packet is erroneous, its content is simply ignored.

Through a line 136, an implanted energizer unit 137 draws energy fromthe high frequency electromagnetic wave signals received by thesignal-receiving device 134. The energizer unit 137 stores the energy ina source of energy, such as a large capacitor, powers the control unit135 and powers the constriction/stimulation unit 110 via a line 138.

The control unit 135 comprises a demodulator and a microprocessor. Thedemodulator demodulates digital signals sent from the signaltransmission device 133. The microprocessor receives the digital packet,decodes it and sends a control signal via a signal line 139 to controlthe constriction device of the constriction/stimulation unit 110 toeither constrict or release the wall portion of the patient's organdepending on the received command code.

FIG. 52 shows a circuitry of an embodiment of the invention, in whichwireless energy is transformed into a current. External components ofthe circuitry include a microprocessor 140, a signal generator 141 and apower amplifier 142 connected thereto. The microprocessor 140 is adaptedto switch the signal generator 141 on/off and to modulate signalsgenerated by the signal generator 141 with digital commands. The poweramplifier 142 amplifies the signals and sends them to an externalsignal-transmitting antenna coil 143. The antenna coil 143 is connectedin parallel with a capacitor 144 to form a resonant circuit tuned to thefrequency generated by the signal generator 141.

Implanted components of the circuitry include a signal receiving antennacoil 145 and a capacitor 146 forming together a resonant circuit that istuned to the same frequency as the transmitting antenna coil 143. Thesignal receiving antenna coil 145 induces a current from the receivedhigh frequency electromagnetic waves and a rectifying diode 147rectifies the induced current, which charges a storage capacitor 148.The storage capacitor 148 powers a motor 149 for driving theconstriction device of the constriction/stimulation unit 110. A coil 150connected between the antenna coil 145 and the diode 147 prevents thecapacitor 148 and the diode 147 from loading the circuit of thesignal-receiving antenna 145 at higher frequencies. Thus, the coil 150makes it possible to charge the capacitor 148 and to transmit digitalinformation using amplitude modulation.

A capacitor 151 and a resistor 152 connected in parallel and a diode 153form a detector used to detect amplitude modulated digital information.A filter circuit is formed by a resistor 154 connected in series with aresistor 155 connected in series with a capacitor 156 connected inseries with the resistor 154 via ground, and a capacitor 157, oneterminal of which is connected between the resistors 154,155 and theother terminal of which is connected between the diode 153 and thecircuit formed by the capacitor 151 and resistor 152. The filter circuitis used to filter out undesired low and high frequencies. The detectedand filtered signals are fed to an implanted microprocessor 158 thatdecodes the digital information and controls the motor 149 via anH-bridge 159 comprising transistors 160, 161, 162 and 163. The motor 149can be driven in two opposite directions by the H-bridge 159.

The microprocessor 158 also monitors the amount of stored energy in thestorage capacitor 148. Before sending signals to activate the motor 149,the microprocessor 158 checks whether the energy stored in the storagecapacitor 148 is enough. If the stored energy is not enough to performthe requested operation, the microprocessor 158 waits for the receivedsignals to charge the storage capacitor 148 before activating the motor149.

Alternatively, the energy stored in the storage capacitor 148 may onlybe used for powering a switch, and the energy for powering the motor 149may be obtained from another implanted energy source of relatively highcapacity, for example a battery. In this case the switch is adapted toconnect the battery to the motor 149 in an on mode when the switch ispowered by the storage capacitor 148 and to keep the batterydisconnected from the motor 149 in a standby mode when the switch is notpowered.

FIGS. 53A-53C show an embodiment of the invention, which is similar tothe embodiment of FIG. 2, except that the constriction/stimulation unit,here denoted by reference numeral 200, is provided with additionalclamping elements. The embodiment of FIGS. 53A-53C is suited foractively moving the fluid and/or other bodily matter in the lumen of apatient's organ. Thus, the constriction/stimulation unit 200 alsoincludes a first pair of short clamping elements 201 and 202, and asecond pair of short clamping elements 203 and 204, wherein the firstand second pairs of clamping elements are positioned at mutual sides ofthe elongate clamping elements 5, 6. The two short clamping elements201, 202 of the first pair are radially movable towards and away fromeach other between retracted positions (FIG. 53A) and clamping positions(FIGS. 53B and 53C), and the two short clamping elements 203, 204 of thesecond pair are radially movable towards and away from each otherbetween retracted positions (FIG. 53C) and clamping positions (FIGS. 53Aand 53B). The stimulation device 3 also includes electrical elements 7positioned on the short clamping elements 201-204, so that theelectrical elements 7 on one of the short clamping elements 201 and 203,respectively, of each pair of short elements face the electricalelements 7 on the other short clamping element 202 and 204,respectively, of each pair of short elements.

The constriction/stimulation unit 200 is applied on a wall portion 8 ofa tubular tissue wall of a patient's organ, so that the short clampingelements 201, 202 are positioned at an upstream end of the wall portion8, whereas the short clamping elements 203, 204 202 are positioned at adownstream end of the wall portion 8. In FIGS. 53A to 53C the upstreamend of the wall portion 8 is to the left and the downstream end of thewall portion 8 is to the right.

The control device 4 controls the pair of short clamping elements 201,202, the pair of elongate clamping elements 5, 6 and the pair of shortelements 203, 204 to constrict and release the wall portion 8independently of one another. The control device also controls theelectrical elements 7 on a clamping element that is constricting thewall portion to stimulate the constricted wall portion 8 with electricpulses to cause contraction of the wall portion 8, so that the lumen ofthe wall portion 8 is closed.

FIGS. 53A-53C illustrate how the control device 4 controls the operationof the constriction/stimulation unit 200 to cyclically move fluid and/orother bodily matter downstream in the lumen of the wall portion 8. Thus,in FIG. 53A the short clamping elements 201, 202 and the elongateclamping elements 5, 6 are in their refracted positions, whereas theshort clamping elements 203, 204 are in their clamping positions whilethe electrical elements 7 on elements 203, 204 electrically stimulatethe wall portion 8. The electrical stimulation causes the wall portion 8at the elements 203, 204 to thicken, whereby the lumen is closed. FIG.53B illustrates how also the short clamping elements 201, 202 have beenmoved radially inwardly to their clamping positions, while theelectrical elements 7 on elements 201, 202 electrically stimulate thewall portion 8, whereby a volume of bodily matter is trapped in thelumen between the upstream and downstream ends of the wall portion 8.FIG. 53C illustrates how initially the short clamping elements 203, 204have been moved radially outwardly to their retracted positions, andthen the elongate clamping elements 5, 6 have been moved radiallyinwardly to their clamping positions while the electrical elements 7 onelements 5, 6 electrically stimulate the wall portion 8. As a result,the bodily matter in the lumen between the upstream and downstream endsof the wall portion 8 has been moved downstream in the lumen Then, thecontrol device 4 controls the constriction/stimulation unit 200 toassume the state shown in FIG. 53A, whereby bodily matter may flow intoand fill the lumen between the upstream and downstream ends of the wallportion 8, so that the cycle of the operation is completed.

Alternatively, the operation cycle of the constriction/stimulation unit200 described above may be reversed, in order to move bodily matterupstream in the lumen. In this case, the control device 4 controls theshort clamping elements 203, 204 to constrict the wall portion 8 at thedownstream end thereof to restrict the flow in the lumen and controlsthe electric elements 7 to stimulate the constricted wall portion 8 withelectric pulses at the downstream end to close the lumen. With the lumenclosed at the downstream end of the constricted wall portion 8 and theshort clamping elements 201, 202 in their retracted positions, as shownin FIG. 53A, the control device 4 controls the elongate clampingelements 5, 6 to constrict the wall portion 8 between the upstream anddownstream ends thereof. As a result, the fluid and/or other bodilymatter contained in the wall portion 8 between the upstream anddownstream ends thereof is moved upstream in the lumen.

Although FIGS. 53A-53C disclose pairs of clamping elements, it should benoted that it is conceivable to design the constriction/stimulation unit200 with only a single short clamping element 201, a single elongateclamping element 5 and a single short clamping element 203. In this casethe bottom of the tubular wall portion 8 is supported by stationaryelements of the constriction/stimulation unit 200 opposite to theclamping elements 201, 5, and 203.

FIGS. 54A and 54B schematically show another embodiment of theinvention, in which a constriction/stimulation unit 205 is designed foractively moving the fluid and/or other bodily matter in the lumen of apatient's tubular organ. The constriction device 206 of theconstriction/stimulation unit 205 includes a rotor 207, which carriesthree cylindrical constriction elements 208A, 208B and 208C positionedequidistantly from the axis 209 of the rotor 207. The constrictionelements 208A-208C may be designed as rollers. Each cylindrical element208A-208C is provided with electrical elements 7. A stationary elongatesupport element 210 is positioned spaced from but close to the rotor 207and has a part cylindrical surface 211 concentric with the axis 209 ofthe rotor 207. The constriction/stimulation unit 205 is applied on apatient's tubular organ 212, so that the organ 212 extends between thesupport element 210 and the rotor 207.

The control device 4 controls the rotor 207 of the constriction deviceto rotate, such that the constriction elements 208A-208C successivelyconstrict wall portions of a series of wall portions of the tubularorgan 212 against the elongate support element 210. The electricalelements 7 of the constriction elements 208A-208C stimulate theconstricted wall portions with electric pulses so that the wall portionsthicken and close the lumen of the organ 212. FIG. 54A illustrates howthe constriction element 208A has started to constrict the wall of theorgan 212 and how the lumen of the organ 212 is closed with the aid ofthe electrical elements 7 on the constriction element 208A, whereas theconstriction element 208B is about to release the organ 212. FIG. 54Billustrates how the constriction element 208A has advanced about halfwayalong the elongate support element 210 and moved the bodily matter inthe lumen in a direction indicated by an arrow. The constriction element208B has released the organ 212, whereas the constriction element 208Cis about to engage the organ 212. Thus, the control device 4 controlsthe rotor 207 to cyclically move the constriction elements 208A-208C,one after the other, along the elongate support element 210, whileconstricting the wall portions of the organ 212, so that the bodilymatter in the organ 212 is moved in a peristaltic manner.

FIGS. 55A, 55B and 55C show another mechanically operable constrictiondevice 213 for use in the apparatus of the invention. Referring to FIG.55A, the constriction device 213 includes a first ring-shaped holder 214applied on a tubular organ 8 of a patient and a second ring-shapedholder 215 also applied on the organ 8 spaced apart from holder 214.There are elastic strings 216 (here twelve strings) that extend inparallel along the tubular organ 8 and interconnect the two holders 213,214 without contacting the organ 8. FIG. 55A illustrate an inactivatedstate of the constriction device 213 in which the organ 8 is notconstricted.

Referring to FIGS. 55B and 55C, when organ 8 is to be constricted thering-shaped holders 213 and 214 are rotated by an operation means (notshown) in opposite directions, whereby the elastic strings 216 constrictthe organ 8 in a manner that appears from FIGS. 55B and 55C. For thesake of clarity, only five strings 216 are shown in FIG. 55B.

In accordance with the present invention, electrodes for electricallystimulating the organ 8 to cause contraction of the wall of the organ 8are attached to the strings 216 (not shown in FIGS. 55A-55C).

FIG. 56 schematically illustrates an arrangement of the apparatus thatis capable of sending information from inside the patient's body to theoutside thereof to give information related to at least one functionalparameter of the apparatus, and/or related to a physical parameter ofthe patient, in order to supply an accurate amount of energy to animplanted internal energy receiver 302 connected to energy consumingcomponents of an implanted constriction/stimulation unit 301 of theapparatus of the invention. Such an energy receiver 302 may include asource of energy and/or an energy-transforming device. Brieflydescribed, wireless energy is transmitted from an external source ofenergy 304 a located outside the patient and is received by the internalenergy receiver 302 located inside the patient. The internal energyreceiver is adapted to directly or indirectly supply received energy tothe energy consuming components of the constriction/stimulation unit 301via a switch 326. An energy balance is determined between the energyreceived by the internal energy receiver 302 and the energy used for theconstriction/stimulation unit 301, and the transmission of wirelessenergy is then controlled based on the determined energy balance. Theenergy balance thus provides an accurate indication of the correctamount of energy needed, which is sufficient to operate theconstriction/stimulation unit 301 properly, but without causing unduetemperature rise.

In FIG. 56 the patient's skin is indicated by a vertical line 305. Here,the energy receiver comprises an energy-transforming device 302 locatedinside the patient, preferably just beneath the patient's skin 305.Generally speaking, the implanted energy-transforming device 302 may beplaced in the abdomen, thorax, muscle fascia (e.g. in the abdominalwall), subcutaneously, or at any other suitable location. The implantedenergy-transforming device 302 is adapted to receive wireless energy Etransmitted from the external source of energy 304 a provided in anexternal energy-transmission device 304 located outside the patient'sskin 305 in the vicinity of the implanted energy-transforming device302.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal source of energy 304 a and an adjacent secondary coil arrangedin the implanted energy-transforming device 302. When an electriccurrent is fed through the primary coil, energy in the form of a voltageis induced in the secondary coil which can be used to power theimplanted energy consuming components of the apparatus, e.g. afterstoring the incoming energy in an implanted source of energy, such as arechargeable battery or a capacitor. However, the present invention isgenerally not limited to any particular energy transfer technique, TETdevices or energy sources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted components of theapparatus. The term “energy used” is then understood to include alsoenergy stored by implanted components of the apparatus. A control deviceincludes an external control unit 304 b that controls the externalsource of energy 304 a based on the determined energy balance toregulate the amount of transferred energy. In order to transfer thecorrect amount of energy, the energy balance and the required amount ofenergy is determined by means of a determination device including animplanted internal control unit 315 connected between the switch 326 andthe constriction/stimulation unit 301. The internal control unit 315 maythus be arranged to receive various measurements obtained by suitablesensors or the like, not shown, measuring certain characteristics of theconstriction/stimulation unit 301, somehow reflecting the requiredamount of energy needed for proper operation of theconstriction/stimulation unit 301. Moreover, the current condition ofthe patient may also be detected by means of suitable measuring devicesor sensors, in order to provide parameters reflecting the patient'scondition. Hence, such characteristics and/or parameters may be relatedto the current state of the constriction/stimulation unit 301, such aspower consumption, operational mode and temperature, as well as thepatient's condition reflected by parametyers such as: body temperature,blood pressure, heartbeats and breathing. Other kinds of physicalparameters of the patient and functional parameters of the device aredescribed elsewhere.

Furthermore, a source of energy in the form of an accumulator 316 mayoptionally be connected to the implanted energy-transforming device 302via the control unit 315 for accumulating received energy for later useby the constriction/stimulation unit 301. Alternatively or additionally,characteristics of such an accumulator, also reflecting the requiredamount of energy, may be measured as well. The accumulator may bereplaced by a rechargeable battery, and the measured characteristics maybe related to the current state of the battery, any electrical parametersuch as energy consumption voltage, temperature, etc. In order toprovide sufficient voltage and current to the constriction/stimulationunit 301, and also to avoid excessive heating, it is clearly understoodthat the battery should be charged optimally by receiving a correctamount of energy from the implanted energy-transforming device 302, i.e.not too little or too much. The accumulator may also be a capacitor withcorresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 315. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 315 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the apparatus, or the patient, or an implanted source ofenergy if used, or any combination thereof. The internal control unit315 is further connected to an internal signal transmitter 327, arrangedto transmit a control signal reflecting the determined required amountof energy, to an external signal receiver 304 c connected to theexternal control unit 304 b. The amount of energy transmitted from theexternal source of energy 304 a may then be regulated in response to thereceived control signal.

Alternatively, the determination device may include the external controlunit 304 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 304 b wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 304 b, thus integrating the above-describedfunction of the internal control unit 315 in the external control unit304 b. In that case, the internal control unit 315 can be omitted andthe sensor measurements are supplied directly to the internal signaltransmitter 327 which sends the measurements over to the external signalreceiver 304 c and the external control unit 304 b. The energy balanceand the currently required amount of energy can then be determined bythe external control unit 304 b based on those sensor measurements.

Hence, the present solution according to the arrangement of FIG. 56employs the feed back of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming components of the apparatus. The apparatus may use thereceived energy either for consuming or for storing the energy in animplanted source of energy or the like. The different parametersdiscussed above would thus be used if relevant and needed and then as atool for determining the actual energy balance. However, such parametersmay also be needed per se for any actions taken internally tospecifically operate the apparatus.

The internal signal transmitter 327 and the external signal receiver 304c may be implemented as separate units using suitable signal transfermeans, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 327 and the externalsignal receiver 304 c may be integrated in the implantedenergy-transforming device 302 and the external source of energy 304 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. In accordance with the presentinvention, such an integrated information feedback and energy systemcomprises an implantable internal energy receiver for receiving wirelessenergy, the energy receiver having an internal first coil and a firstelectronic circuit connected to the first coil, and an external energytransmitter for transmitting wireless energy, the energy transmitterhaving an external second coil and a second electronic circuit connectedto the second coil. The external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver. This system further comprises a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off. Inimplementing this system in the arrangement of FIG. 17, the switch 326is either separate and controlled by the internal control unit 315, orintegrated in the internal control unit 315. It should be understoodthat the switch 326 should be interpreted in its broadest embodiment.This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.

To conclude, the energy supply arrangement illustrated in FIG. 56 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 315 of the determination device.A control signal reflecting the required amount of energy is alsocreated by the internal control unit 315, and the control signal istransmitted from the internal signal transmitter 327 to the externalsignal receiver 304 c. Alternatively, the energy balance can bedetermined by the external control unit 304 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement results from various sensors. The amount of energyemitted from the external source of energy 304 a can then be regulatedby the external control unit 304 b, based on the determined energybalance, e.g. in response to the received control signal. This processmay be repeated intermittently at certain intervals during ongoingenergy transfer, or may be executed on a more or less continuous basisduring the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external source of energy 304 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics. This system may also be used to obtain informationabout the coupling factors between the coils in a TET system even tocalibrate the system both to find an optimal place for the external coilin relation to the internal coil and to optimize energy transfer. Simplycomparing in this case the amount of energy transferred with the amountof energy received. For example if the external coil is moved thecoupling factor may vary and correctly displayed movements could causethe external coil to find the optimal place for energy transfer.Preferably, the external coil is adapted to calibrate the amount oftransferred energy to achieve the feedback information in thedetermination device, before the coupling factor is maximized.

This coupling factor information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorbetween the first and second coils. The energy transmitter may regulatethe transmitted energy in response to the obtained coupling factor.

With reference to FIG. 57, although wireless transfer of energy foroperating the apparatus has been described above to enable non-invasiveoperation, it will be appreciated that the apparatus can be operatedwith wire bound energy as well. Such an example is shown in FIG. 57,wherein an external switch 326 is interconnected between the externalsource of energy 304 a and an operation device, such as an electricmotor 307 operating the constriction/stimulation unit 301. An externalcontrol unit 304 b controls the operation of the external switch 326 toeffect proper operation of the constriction/stimulation unit 301.

FIG. 58 illustrates different embodiments for how received energy can besupplied to and used by the constriction/stimulation unit 301. Similarto the example of FIG. 56, an internal energy receiver 302 receiveswireless energy E from an external source of energy 304 a which iscontrolled by a transmission control unit 304 b. The internal energyreceiver 302 may comprise a constant voltage circuit, indicated as adashed box “constant V” in FIG. 58, for supplying energy at constantvoltage to the constriction/stimulation unit 301. The internal energyreceiver 302 may further comprise a constant current circuit, indicatedas a dashed box “constant C” in the figure, for supplying energy atconstant current to the constriction/stimulation unit 301.

The constriction/stimulation unit 301 comprises an energy consuming part301 a, which may be a motor, pump, restriction device, or any othermedical appliance that requires energy for its electrical operation. Theconstriction/stimulation unit 301 may further comprise an energy storagedevice 301 b for storing energy supplied from the internal energyreceiver 302. Thus, the supplied energy may be directly consumed by theenergy consuming part 301 a, or stored by the energy storage device 301b, or the supplied energy may be partly consumed and partly stored. Theconstriction/stimulation unit 301 may further comprise an energystabilizing unit 301 c for stabilizing the energy supplied from theinternal energy receiver 302. Thus, the energy may be supplied in afluctuating manner such that it may be necessary to stabilize the energybefore consumed or stored.

The energy supplied from the internal energy receiver 302 may further beaccumulated and/or stabilized by a separate energy stabilizing unit 328located outside the constriction/stimulation unit 301, before beingconsumed and/or stored by the constriction/stimulation unit 301.Alternatively, the energy stabilizing unit 328 may be integrated in theinternal energy receiver 302. In either case, the energy stabilizingunit 328 may comprise a constant voltage circuit and/or a constantcurrent circuit.

It should be noted that FIG. 56 and FIG. 58 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional components and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the presentinvention.

FIG. 59 schematically shows an energy balance measuring circuit of oneof the proposed designs of the apparatus for controlling transmission ofwireless energy, or energy balance. The circuit has an output signalcentered on 2.5V and proportionally related to the energy imbalance. Thederivative of this signal shows if the value goes up and down and howfast such a change takes place. If the amount of received energy islower than the energy used by implanted components of the apparatus,more energy is transferred and thus charged into the source of energy.The output signal from the circuit is typically fed to an ND converterand converted into a digital format. The digital information can then besent to the external energy-transmission device allowing it to adjustthe level of the transmitted energy. Another possibility is to have acompletely analog system that uses comparators comparing the energybalance level with certain maximum and minimum thresholds sendinginformation to external energy-transmission device if the balance driftsout of the max/min window.

The schematic FIG. 59 shows a circuit implementation for a system thattransfers energy to the implanted energy components of the apparatus ofthe present invention from outside of the patient's body using inductiveenergy transfer. An inductive energy transfer system typically uses anexternal transmitting coil and an internal receiving coil. The receivingcoil, LI, is included in the schematic FIG. 59; the transmitting partsof the system are excluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 20and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 59 the symbols Y1, Y2, Y3 and so on symbolize test points withinthe circuit. The components in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil LI.Energy to implanted components is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

The embodiments described in connection with FIGS. 56, 58 and 59identify a general method for controlling transmission of wirelessenergy to implanted energy consuming components of the apparatus of thepresent invention. Such a method will be defined in general terms in thefollowing.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming components of an apparatusas described above. The wireless energy E is transmitted from anexternal source of energy located outside the patient and is received byan internal energy receiver located inside the patient, the internalenergy receiver being connected to the implanted energy consumingcomponents of the apparatus for directly or indirectly supplyingreceived energy thereto. An energy balance is determined between theenergy received by the internal energy receiver and the energy used forthe operation of the implanted parts of the apparatus. The transmissionof wireless energy E from the external source of energy is thencontrolled based on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external source of energy to a secondary coil in the internalenergy receiver. A change in the energy balance may be detected tocontrol the transmission of wireless energy based on the detected energybalance change. A difference may also be detected between energyreceived by the internal energy receiver and energy used for theoperation of the implanted parts of the apparatus, to control thetransmission of wireless energy based on the detected energy difference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the operation of the implantedparts of the apparatus be consumed to operate the implanted parts of theapparatus and/or stored in at least one implanted energy storage deviceof the apparatus.

When electrical and/or physical parameters of the implanted parts of theapparatus and/or physical parameters of the patient are determined, theenergy may be transmitted for consumption and storage according to atransmission rate per time unit which is determined based on saidparameters. The total amount of transmitted energy may also bedetermined based on said parameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external source of energymay be controlled by applying to the external source of energyelectrical pulses from a first electric circuit to transmit the wirelessenergy, the electrical pulses having leading and trailing edges, varyingthe lengths of first time intervals between successive leading andtrailing edges of the electrical pulses and/or the lengths of secondtime intervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external sourceof energy may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

The embodiments described in connection with FIGS. 56, 58 and 59 alsoidentify general features for controlling transmission of wirelessenergy to implanted energy consuming components of the apparatus of thepresent invention. Such features of the apparatus will be defined ingeneral terms in the following.

In its broadest sense, the apparatus comprises a control device forcontrolling the transmission of wireless energy from anenergy-transmission device, and an implantable internal energy receiverfor receiving the transmitted wireless energy, the internal energyreceiver being connected to implantable energy consuming components ofthe apparatus for directly or indirectly supplying received energythereto. The apparatus further comprises a determination device adaptedto determine an energy balance between the energy received by theinternal energy receiver and the energy used for the implantable energyconsuming components of the apparatus, wherein the control devicecontrols the transmission of wireless energy from the externalenergy-transmission device, based on the energy balance determined bythe determination device.

Further, the apparatus of the invention may comprise any of thefollowing features:

-   -   A primary coil in the external source of energy adapted to        transmit the wireless energy inductively to a secondary coil in        the internal energy receiver.    -   The determination device is adapted to detect a change in the        energy balance, and the control device controls the transmission        of wireless energy based on the detected energy balance change.    -   The determination device is adapted to detect a difference        between energy received by the internal energy receiver and        energy used for the implantable energy consuming components of        the apparatus, and the control device controls the transmission        of wireless energy based on the detected energy difference.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy balance change implies that the energy        balance is increasing, or vice versa, wherein the        decrease/increase of energy transmission corresponds to a        detected change rate.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy difference implies that the received energy        is greater than the used energy, or vice versa, wherein the        decrease/increase of energy transmission corresponds to the        magnitude of said detected energy difference.    -   The energy used for implanted parts of the apparatus is consumed        to operate the implanted parts, and/or stored in at least one        energy storage device of the apparatus.    -   Where electrical and/or physical parameters of the apparatus        and/or physical parameters of the patient are determined, the        energy-transmission device transmits the energy for consumption        and storage according to a transmission rate per time unit which        is determined by the determination device based on said        parameters. The determination device also determines the total        amount of transmitted energy based on said parameters.    -   When a difference is detected between the total amount of energy        received by the internal energy receiver and the total amount of        consumed and/or stored energy, and the detected difference is        related to the integral over time of at least one measured        electrical parameter related to the energy balance, the        determination device determines the integral for a monitored        voltage and/or current related to the energy balance.    -   When the derivative is determined over time of a measured        electrical parameter related to the amount of consumed and/or        stored energy, the determination device determines the        derivative for a monitored voltage and/or current related to the        energy balance.    -   The energy-transmission device comprises a coil placed        externally to the human body, and an electric circuit is        provided to power the external coil with electrical pulses to        transmit the wireless energy. The electrical pulses have leading        and trailing edges, and the electric circuit is adapted to vary        first time intervals between successive leading and trailing        edges and/or second time intervals between successive trailing        and leading edges of the electrical pulses to vary the power of        the transmitted wireless energy. As a result, the energy        receiver receiving the transmitted wireless energy has a varied        power.    -   The electric circuit is adapted to deliver the electrical pulses        to remain unchanged except varying the first and/or second time        intervals.    -   The electric circuit has a time constant and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the coil is varied.    -   The electric circuit is adapted to deliver the electrical pulses        to be varied by only varying the lengths of first time intervals        between successive leading and trailing edges of the electrical        pulses.    -   The electric circuit is adapted to supplying a train of two or        more electrical pulses in a row, said train having a first        electrical pulse at the start of the pulse train and having a        second electrical pulse at the end of the pulse train, and    -   the lengths of the second time intervals between successive        trailing edge of the second electrical pulse in a first pulse        train and leading edge of the first electrical pulse of a second        pulse train are varied by the first electronic circuit.    -   The electric circuit is adapted to provide the electrical pulses        as pulses having a substantially constant height and/or        amplitude and/or intensity and/or voltage and/or current and/or        frequency.    -   The electric circuit has a time constant, and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the first coil are varied.    -   The electric circuit is adapted to provide the electrical pulses        varying the lengths of the first and/or the second time        intervals only within a range that includes the first time        constant or that is located relatively close to the first time        constant, compared to the magnitude of the first time constant.

While the invention has been described in connection with what ispresently considered to be the most practical and preferred embodiment,it is to be understood that the invention is not to be limited to thedisclosed embodiment, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the appended claims.

1-1192. (canceled)
 1193. An apparatus for controlling the flow of urinein a urethra of a patient, comprising: an implantable adjustableconstriction device for constricting the urethra to influence the flowin the urinary tract; a control device for controlling the constrictiondevice, wherein the control device is configured to control theconstriction device to constrict the urethra or to release aconstriction of the urethra; and an operation device for operating theconstriction device to change the constriction of the urethra; and anenergy source for supplying energy for the operation device; wherein thecontrol device comprises a temperature sensor configured to sense atemperature of the apparatus or a temperature of the patient.
 1194. Theapparatus according to claim 1193, wherein the control device furthercomprises an internal signal transmitter arranged to transmit a signalbased on the temperature measurements.
 1195. The apparatus according toclaim 1194, wherein the internal signal transmitter is arranged totransmit the signal to an external signal receiver.
 1196. The apparatusaccording to claim 1193, wherein the temperature sensor is configured tomeasure the temperature on a regular basis, and wherein the controldevice is configured to store the measured values.
 1197. The apparatusaccording to claim 1193, wherein the control device further comprises animplantable sensor configured to sense a physical parameter, and whereinthe control device is adapted to produce an indication in response tothe sensor sensing the physical parameter.
 1198. An apparatus forcontrolling a flow of urine in a urethra of a patient, comprising: animplantable constriction device for constricting the urethra toinfluence the flow in the urinary tract, the constriction devicecomprising a plurality of clamping elements configured to be arranged ina common plane intersecting the urethra and to be radially movabletowards and away from a central axis of the urethra to change aconstriction of the urethra; an operation device configured to operatethe movement of the clamping elements; an implantable motor configuredto operate the operation device; and a gear box configured to transfer aforce generated by the motor into a force operating the operationdevice; wherein the operation device is configured to operate themovement of the clamping elements such that the movement ispredominantly inelastic, and such that a clamping force, acting on theurethra, is distributed between the clamping elements.
 1199. Theapparatus according to claim 1198, wherein the clamping force, acting onthe urethra, is distributed substantially evenly between the clampingelements.
 1200. The apparatus according to claim 1198, wherein theplurality of clamping elements comprises a first and a second clampingelement configured to be arranged at least one of 120° and 180° apartalong the circumference.
 1201. The apparatus according to claim 1198,wherein the operation device is configured to cause the constrictiondevice to assume a constricted state in which the flow of urine in theurethra is hindered, and a released state in which the urine is allowedto flow through the urethra.
 1202. The apparatus according to claim1198, wherein the operation device is configured to be coupled to eachof the clamping elements so as to transmit the clamping force pushingthe clamping elements towards the central axis.
 1203. The apparatusaccording to claim 1198, wherein the operation device is configured todistribute the clamping force between the clamping elements such thatthe flow of urine the urethra is constricted while allowing the bloodcirculation in a wall of the constricted portion of the urethra to besubstantially unrestricted.
 1204. An apparatus for controlling the flowof urine in a urethra of a patient, comprising: an implantableadjustable constriction device for constricting the urethra to influencethe flow in the urinary tract; an operation device for operating theconstriction device to change the constriction of the urethra; a controldevice for controlling the operation device, wherein the control deviceis configured to: control the operation device to constrict the urethra,and control the operation device to release the urethra; and an energysource for supplying energy to the operation device; wherein the controldevice is configured to determine the current state of the energysource, and wherein the control unit is connected to an internal signaltransmitter configured to transmit information related to the currentstate of the energy source.
 1205. The apparatus according to claim 1204,wherein the energy source comprises a battery.
 1206. The apparatusaccording to claim 1205, wherein the battery is at least one of arechargeable battery and a capacitor.
 1207. The apparatus according toclaim 1204, wherein the control device is configured to measure aparameter related to a voltage of the energy source to determine thecurrent state of the energy source.
 1208. The apparatus according toclaim 1204, wherein the control device is configured to measure aparameter related to the energy consumption to determine the currentstate of the energy source.
 1209. The apparatus according to claim 1204,wherein the control device is configured to measure a parameter relatedto the temperature of the energy source to determine the current stateof the energy source.
 1210. The apparatus according to claim 1204,wherein the control device is arranged to store measurements related toa current state of the energy source.
 1211. The apparatus according toclaim 1210, wherein the control device is arranged to transmit a controlsignal reflecting at least a portion of the stored measurements. 1212.The apparatus according to claim 1204, wherein the control device isarranged to measure a current state of the energy source on a regularbasis.